Sodium Fluoride Chewable Tablets
Fluoride Chewable Tablets 1 mg
Active Ingredient: 1 mg of fluoride ion from 2.2 mg of sodium fluoride (NaF).
Inactive Ingredients: Lactose, Saccharine, Cherry Flavor, D&C Red #7 Calcium Lake, Magnesium Stearate.
DOSAGE AND ADMINISTRATION:Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.
STORAGE:Store at a Controlled Room Temperature 20?-25?C (68?-77?F)
743634
Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11 172-12
NDC 51862-172-12
Fluoride Chewable Tablets
1 mg
(From 2.2 mg of Sodium Fluoride)
Cherry Flavor 120 Tablets Rx Only
Libertas
Pharma Inc.
FLUORIDE
fluoride tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51862-172 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg Inactive Ingredients Ingredient Name Strength CHERRY LACTOSE SACCHARIN D&C RED NO. 7 MAGNESIUM STEARATE Product Characteristics Color RED Score no score Shape ROUND Size 6mm Flavor CHERRY Imprint Code 172 Contains Packaging # NDC Package Description Multilevel Packaging 1 51862-172-12 120 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/21/2011
Labeler - Libertas Pharma, Inc. (962128943) Revised: 05/2011Libertas Pharma, Inc.
Fluoritab Fluoride Drops
Generic Name: sodium fluoride
Dosage Form: oral drops
Fluoritab Fluoride Drops 1 fluid ounce size
CONTAINS: SODIUM FLUORIDE IN AN AQUEOUS VEHICLE WITH PRESERVATIVE.
EACH 8 DROPS EQUIVALENT TO 1 MG. F. (FROM 2.2 MG SODIUM FLUORIDE)
PPM FLUORIDE ION DAILY DOSAGE
IN DRINKING WATER AGE 6 MO. – 3 YRS. AGE 3-6 YRS. AGE 6-16 YRS.
LESS THAN 0.3 PPM 2 DROPS 4 DROPS 8 DROPS
0.3 TO 0.6 PPM NONE 2 DROPS 4 DROPS
OVER 0.6 PPM NONE NONE NONE
KEEP OUT OF REACH OF CHILDREN.CAUTION: FEDERAL (U.S.A.) LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.
CONTRAINDICATIONS: PATIENTS WITH MEDICAL CONDITION OF DENTAL FLUOROSIS.
PRODUCT CATEGORY: DENTAL CARIES PROPHYLACTIC, NUTRITIONAL SUPPLEMENT (MINERAL)
ACTIONS AND INDICATIONS: FLUORITAB DROPS CONTAINING SODIUM FLUORIDE (SYSTEMIC) IS INDICATED AS A DIETARY SUPPLEMENT FOR PREVENTION OF DENTAL CARIES IN CHILDREN IN THE AREAS WHERE THE LEVEL OF FLUORIDE IN DRINKING WATER IS INADEQUATE.
EXCESSIVE DOSES OF SODIUM FLUORIDE MAY RESULT IN FLUOROSIS OF TEETH IF TAKEN DURING FORMATION YEARS. Fluoritab Fluoride Drops
DISTRIBUTED BY:
FLUORITAB CORPORATION
"BETTER TEETH - BETTER HEALTH"
MUSKEGON, MI 49441
MADE IN U.S.A.
FLUORIDE DROPS
sodium fluoride liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0288-5523 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER METHYLPARABEN Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 0288-5523-01 30 mL In 1 BOTTLE, DROPPER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/09/2011
Labeler - Fluoritab Corporation (005376702) Registrant - Fluoritab Corporation (005376702) Establishment Name Address ID/FEI Operations Medical Products Laboratories 002290302 manufacture, analysis Establishment Name Address ID/FEI Operations Fluoritab Corporation 005376702 label Revised: 05/2011Fluoritab Corporation
More Fluoritab Fluoride Drops resources Fluoritab Fluoride Drops Use in Pregnancy & BreastfeedingDrug ImagesFluoritab Fluoride Drops Support Group0 Reviews for Fluoritab Fluoride - Add your own review/rating Compare Fluoritab Fluoride Drops with other medications Prevention of Dental Caries
Gelato Fluoride Foam
Generic Name: sodium fluoride
Dosage Form: aerosol, foam
This is a prescription fluoride treatment foam used to help prevent dental decay.
Do not swallow. Keep out of reach of children. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture on incinerate container. Do not spray toward open flame. For professional use only.
Distilled water, Polaxamer, Triethanolamine, Phosphoric Acid, Sodium Saccharine, Sodium Laureth Sulfate, Hydrofluoric Acid, Xylitol, Potassium Hydroxide, Propellant A31.
GELATO FLUORIDE
sodium fluoride aerosol, foam Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68400-113 Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.5375 g in 125 g Inactive Ingredients Ingredient Name Strength WATER POLOXAMER 407 TROLAMINE PHOSPHORIC ACID SACCHARIN SODIUM SODIUM BENZOATE SODIUM LAURETH SULFATE HYDROFLUORIC ACID XYLITOL Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 68400-113-12 125 g In 1 BOTTLE, SPRAY None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/18/2012
Labeler - Deepak Products, inc. (124886743) Establishment Name Address ID/FEI Operations Deepak Products, inc. 124886743 manufacture Revised: 01/2012Deepak Products, inc.
Sodium Fluoride Cream
Pronunciation: SO-dee-um FLOR-ide
Generic Name: Sodium Fluoride
Brand Name: Examples include Phos-Flur and PreviDent
Sodium Fluoride Cream is used for:
Preventing dental caries.
Sodium Fluoride Cream is a fluoride-containing toothpaste. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.
Do NOT use Sodium Fluoride Cream if: you are allergic to any ingredient in Sodium Fluoride Cream you have trouble swallowingContact your doctor or health care provider right away if any of these apply to you.
Before using Sodium Fluoride Cream:Some medical conditions may interact with Sodium Fluoride Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substancesSome MEDICINES MAY INTERACT with Sodium Fluoride Cream. However, no specific interactions with Sodium Fluoride Cream are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sodium Fluoride Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Sodium Fluoride Cream:Use Sodium Fluoride Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Brush your teeth with a small amount of Sodium Fluoride Cream. Swish it around your mouth for about 1 minute and then spit it out. Do not swallow it. Do not eat, drink, or rinse your mouth for 30 minutes after using Sodium Fluoride Cream. If you miss a dose of Sodium Fluoride Cream, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.Ask your health care provider any questions you may have about how to use Sodium Fluoride Cream.
Important safety information: Do not exceed the dose recommended by your doctor or dentist. Notify your dentist if your teeth become spotted or stained. Caution is advised when using Sodium Fluoride Cream in CHILDREN; they may be more sensitive to its effects PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Sodium Fluoride Cream, discuss with your doctor the benefits and risks of using Sodium Fluoride Cream during pregnancy. It is not known if Sodium Fluoride Cream is found in breast milk. If you are or will be breast-feeding while you are using Sodium Fluoride Cream, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Sodium Fluoride Cream:All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Sodium Fluoride Cream. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; extreme thirst; increased drooling; muscle weakness; nausea; paleness of the skin; seizures; shallow, rapid breathing; shaking; stomach pain; vomiting; weak or fast heartbeat.
Proper storage of Sodium Fluoride Cream:Store Sodium Fluoride Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sodium Fluoride Cream out of the reach of children and away from pets.
General information: If you have any questions about Sodium Fluoride Cream, please talk with your doctor, pharmacist, or other health care provider. Sodium Fluoride Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is a summary only. It does not contain all information about Sodium Fluoride Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Sodium Fluoride resources Sodium Fluoride Use in Pregnancy & Breastfeeding Sodium Fluoride Support Group 3 Reviews for Sodium Fluoride - Add your own review/rating Compare Sodium Fluoride with other medications Prevention of Dental CariesSodium Fluoride/Potassium Nitrate
Pronunciation: SOE-dee-um FLUR-ide/po-TAS-ee-um NYE-trate
Generic Name: Sodium Fluoride/Potassium Nitrate
Brand Name: PreviDent 5000 Sensitive
Sodium Fluoride/Potassium Nitrate is used for:
Preventing tooth decay. It is also used to help reduce painful sensitivity of the teeth to touch; sweets; or hot, cold, or acidic substances.
Sodium Fluoride/Potassium Nitrate is a topical fluoride toothpaste. It works by strengthening the tooth enamel.
Do NOT use Sodium Fluoride/Potassium Nitrate if: you are allergic to any ingredient in Sodium Fluoride/Potassium NitrateContact your doctor or health care provider right away if any of these apply to you.
Before using Sodium Fluoride/Potassium Nitrate:Some medical conditions may interact with Sodium Fluoride/Potassium Nitrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have kidney problemsSome MEDICINES MAY INTERACT with Sodium Fluoride/Potassium Nitrate. However, no specific interactions with Sodium Fluoride/Potassium Nitrate are known at this time.
Ask your health care provider if Sodium Fluoride/Potassium Nitrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Sodium Fluoride/Potassium Nitrate:Use Sodium Fluoride/Potassium Nitrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Use Sodium Fluoride/Potassium Nitrate in place of your regular toothpaste unless your doctor tells you otherwise. Place at least a 1-inch strip of the paste onto a soft bristle toothbrush. Brush the teeth thoroughly for at least 1 minute, then spit out the paste. Do NOT swallow. Rinse the mouth well. Spit out the rinse water. Be sure to brush all sensitive areas of the teeth. Use Sodium Fluoride/Potassium Nitrate on a regular schedule to get the most benefit from it. Using Sodium Fluoride/Potassium Nitrate at the same time each day will help you remember to use it. If you miss a dose of Sodium Fluoride/Potassium Nitrate, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.Ask your health care provider any questions you may have about how to use Sodium Fluoride/Potassium Nitrate.
Important safety information: Do NOT use more than the recommended dose or use for longer than 4 weeks without checking with your doctor. If your symptoms do not get better or if they get worse, check with your doctor. Sodium Fluoride/Potassium Nitrate may cause harm if a large amount is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Sodium Fluoride/Potassium Nitrate should not be used in CHILDREN younger than 12 years old without checking with your doctor or dentist; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sodium Fluoride/Potassium Nitrate while you are pregnant. It is not known if Sodium Fluoride/Potassium Nitrate is found in breast milk after topical use. If you are or will be breast-feeding while you use Sodium Fluoride/Potassium Nitrate, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Sodium Fluoride/Potassium Nitrate:All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bloody vomit; burning in the mouth; diarrhea; drooling; nausea; sore tongue; stomach pain or cramping; or vomiting.
Proper storage of Sodium Fluoride/Potassium Nitrate:Store Sodium Fluoride/Potassium Nitrate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sodium Fluoride/Potassium Nitrate out of the reach of children and away from pets.
General information: If you have any questions about Sodium Fluoride/Potassium Nitrate, please talk with your doctor, pharmacist, or other health care provider. Sodium Fluoride/Potassium Nitrate is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is a summary only. It does not contain all information about Sodium Fluoride/Potassium Nitrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Sodium Fluoride/Potassium Nitrate resources Sodium Fluoride/Potassium Nitrate Use in Pregnancy & Breastfeeding Sodium Fluoride/Potassium Nitrate Support Group 3 Reviews for Sodium Fluoride/Potassium Nitrate - Add your own review/rating Compare Sodium Fluoride/Potassium Nitrate with other medications Prevention of Dental CariesNeutra Maxx
Dosage Form: oral gel
ACTIVE INGREDIENTS
ACTIVE INGREDIENT PURPOSE
SODIUM FLUORIDE (NaF) 1.1% (w/v) ANTICAVITY
INACTIVE INGREDIENTS
DEIONIZED WATER, XYLITOL, POTASSIUM NITRATE, SODIUM CARBOXYMETHYLCELLOSE, GLYCERIN, FLAVORING,SODIUM SACCHARIN, SODIUM PHOSPHATE .
USE: AIDS IN THE PREVENTION OF DENTAL DECAY IN PEDIATRIC PATIENTS AND ADULTS
KEEP OUT OF REACH OF CHILDRENKEEP OUT OF REACH OF CHILDREN. IF MORE SOLUTION IS ACCIDENTALLY SWALLOWED THAN USED FOR BRUSHING, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
DIRECTIONSDIRECTIONS: (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL)
ADULTS AND CHILDREN 6 YEARS AND OLDER: USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE. AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE. BEFORE BEDTIME IS BEST. ADULTS SHOULD EXPECTORATE AFTER USE. CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH THOROUGHLY. DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE.
WHEN USING THIS PRODUCT DO NOT SWALLOW UNLESS TOLD TO DO SO BY A DENTIST OR PHYSICIAN.
PACKAGE LABELNeutra Maxx 5000PPM GEL REFRESHING MINT FLAVOR
THE MAXIMUM AMOUNT OF FLUORIDE AVAILABLE 1.1% SODIUM FLUORIDE 5% POTASSIUM NITRATE XYLITOL SLS FREE Rx ONLY. NET WT 4.3 oz (120 g)
MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS GRAVETTE, AR 72736 THE MEDICINE AVAILABLE EXCLUSIVELY THROUGH YOUR DENTAL OFFICE.
OTHER INFORMATION: STORE AT ROOM TEMPERATURE QUESTION? COMMENTS? CALL 1-479-787-5168 M-F 9AM TO 5PM CST
Neutra Maxx 5000
sodium fluoride gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-504 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.428 g in 120 g Inactive Ingredients Ingredient Name Strength WATER XYLITOL POTASSIUM NITRATE CARBOXYMETHYLCELLULOSE SODIUM GLYCERIN SODIUM PHOSPHATE SACCHARIN SODIUM DIHYDRATE Product Characteristics Color Score Shape Size Flavor MINT (Mint) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-504-06 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Operations Massco Dental A Division of Dunacin Pharmaceuticals 008081858 manufacture Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals
CaviRinse Sodium Fluoride Oral Rinse
Dosage Form: oral mouthwash
CaviRinse™
0.2% Sodium Fluoride Oral Rinse
DESCRIPTION:
CaviRinse oral rinse is a prescription formulation for use in the prevention of dental caries. This formulation contains 0.2% sodium fluoride in a neutral pH base to help prevent caries and enhance remineralization.
ACTIVE INGREDIENT: Sodium Fluoride 0.2% w/v.
INACTIVE INGREDIENTS: Water, Glycerine, Microdent® (Ultramulsion® of dimethicone and poloxamer), sodium saccharin, flavoring, cetylpyridinum chloride.
CLINICAL PHARMACOLOGY:The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. CaviRinse oral rinse provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges.
INDICATIONS AND USAGE:CaviRinse oral rinse is indicated for use as part of a professional program for the prevention and control of dental caries. CaviRinse oral rinse should be swished vigorously between your teeth once weekly after brushing with conventional toothpaste, unless otherwise instructed by a dental professional.
CONTRAINDICATIONS:Do not use in children less than 6 years of age unless recommended by a dental professional.
WARNINGS:DO NOT SWALLOW. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.
ADVERSE REACTIONS:Allergic reactions and other idiosyncrasies have been rarely reported.
OVERDOSAGE:Medical attention should be sought if more than a standard dose is accidentally swallowed. A single 10ml application of CaviRinse oral rinse contains approximately 9mg of fluoride ion.
DOSAGE AND ADMINISTRATION:Follow these instructions unless otherwise instructed by a dental professional. Use once weekly after brushing your teeth with a toothpaste. Pour 10ml of CaviRinse oral rinse into the dosage cup, vigorously swish between your teeth for one minute and then spit out. Children 6 to 16 years of age should thoroughly rinse mouth with water.
HOW SUPPLIED:8oz (236.59ml) of rinse in a plastic bottle with dosage cup.
STORAGE: Do not freeze or expose to extreme heat.
Rx Only
Vanilla Mint Flavor – NDC 48878-3223-8
Made in U.S.A. by
3M ESPE
Dental Products
St. Paul, MN 55144-1000 U.S.A.
1-800-634-2249
CaviRinse is a trademark of 3M or 3M ESPE AG. MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.
© 3M 2010. All rights reserved.
Principal Display Panel – Carton LabelNDC 48878-3223-8
Mint
3M ESPE
CaviRinse™
0.2 % Sodium Fluoride
Oral Rinse
Rx Only
Keep out of reach of children.
IMPORTANT: Read
directions thoroughly.
OMNI™
Contents:
8 fl oz
(236.59ml)
Principal Display Panel – Bottle LabelNDC 48878-3223-8
Mint
3M ESPE
CaviRinse™
0.2 % Sodium Fluoride
Oral Rinse
Rx Only
Keep out of reach of children.
IMPORTANT: Read
directions thoroughly.
OMNI™
Contents:
8 fl oz
(236.59ml)
CAVIRINSE
sodium fluoride mouthwash Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48878-3223 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) sodium fluoride 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength water glycerin saccharin sodium cetylpyridinium chloride anhydrous Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 48878-3223-8 1 BOTTLE In 1 BOX contains a BOTTLE 1 236.59 mL In 1 BOTTLE This package is contained within the BOX (48878-3223-8)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2005
Labeler - 3M ESPE Dental Products (799975909) Establishment Name Address ID/FEI Operations 3M ESPE Dental Products 799975909 MANUFACTURE Revised: 08/20093M ESPE Dental Products
More CaviRinse Sodium Fluoride Oral Rinse resources CaviRinse Sodium Fluoride Oral Rinse Use in Pregnancy & Breastfeeding CaviRinse Sodium Fluoride Oral Rinse Support Group 3 Reviews for CaviRinse Sodium Fluoride Oral - Add your own review/rating Compare CaviRinse Sodium Fluoride Oral Rinse with other medications Prevention of Dental Caries
ControlRx Toothpaste
Dosage Form: oral paste, dentifrice
ControlRx™
1.1% Sodium Fluoride Prescription Toothpaste
DESCRIPTION:
ControlRx dentifrice is a prescription formulation for use in the prevention of dental caries. This formulation contains 1.1% sodium fluoride in a neutral pH base and a mild abrasive to help remove dental plaque, debris and stain.
ACTIVE INGREDIENT: Sodium Fluoride 1.1% w/w.
INACTIVE INGREDIENTS: Water, Sorbitol, Hydrated Silica, Glycerin, MICRODENT® 2.0% w/w - a patented ULTRAMULSION® of Dimethicone and Poloxamer 407, PEG 12, Flavor, Cellulose Gum, Sodium Lauryl Sulfate, Titanium Dioxide, Sodium Saccharin.
CLINICAL PHARMACOLOGY:The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. ControlRx dentifrice provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges, relative to over the counter fluoride products.
INDICATIONS AND USAGE:ControlRx dentifrice is indicated for use as part of a professional program for the prevention and control of dental caries. ControlRx dentifrice is applied to the teeth using a toothbrush. ControlRx dentifrice should be used once daily in place of a conventional toothpaste, unless otherwise instructed by a dental professional.
CONTRAINDICATIONS:Do not use in children less than 6 years of age unless recommended by a dental professional.
WARNINGS:Do not swallow. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6 ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.
ADVERSE REACTIONS:Allergic reactions and other idiosyncrasies have been rarely reported.
OVERDOSAGE:Medical attention should be sought if more than a thin ribbon or pea-sized amount is accidentally swallowed. A thin ribbon or pea-sized amount of ControlRx dentifrice weighs approximately 0.3g and contains approximately 1.5mg of fluoride ion. A 2 oz tube contains 282mg of fluoride ion.
DOSAGE AND ADMINISTRATION:Follow these instructions unless otherwise instructed by a dental professional. Use once daily.
Apply a thin ribbon or pea-sized amount of ControlRx dentifrice to a soft-bristled toothbrush, and brush teeth for two minutes. After brushing, adults should expectorate. Children 6 to 16 years of age should expectorate and thoroughly rinse mouth with water.
HOW SUPPLIED:2 oz (57g) net wt. of paste in laminate tubes.
STORAGE: Do not freeze or expose to extreme heat.
Rx Only
Refreshing Berry Flavor: 2 oz tube - NDC 48878-3101-6.
MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.
Principal Display Panel – Box Label3M ESPE
NDC 48878-3101-6
ControlRx™
Berry
1.1% Sodium Fluoride
5000 ppm F- Prescription ToothpasteOMNI™
Rx Only
Contents: 1 Tube
NET WT 2oz (57g)
Principal Display Panel – Tube Label3M ESPE
NDC 48878-3101-6
ControlRx™
Berry
1.1% Sodium Fluoride
5000 ppm F- Prescription Toothpaste
Rx Only
OMNI™
NET WT
2oz (57g)
CONTROLRX
sodium fluoride paste, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48878-3101 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) sodium fluoride 11 mg in 1 g Inactive Ingredients Ingredient Name Strength Water Sorbitol Silicon Dioxide Glycerin Dimethicone Poloxamer 407 Polyethylene Glycol Carboxymethylcellulose Sodium Sodium Lauryl Sulfate Titanium Dioxide Saccharin Sodium Product Characteristics Color Score Shape Size Flavor BERRY (BERRY) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 48878-3101-6 1 TUBE In 1 BOX contains a TUBE 1 57 g In 1 TUBE This package is contained within the BOX (48878-3101-6)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2005
Labeler - 3M ESPE Dental Products (799975909) Revised: 05/20103M ESPE Dental Products
More ControlRx Toothpaste resources ControlRx Toothpaste Use in Pregnancy & BreastfeedingControlRx Toothpaste Support Group3 Reviews for ControlRx Toothpaste - Add your own review/rating Compare ControlRx Toothpaste with other medications Prevention of Dental Caries
Multi Vitamin with Fluoride
Dosage Form: tablet, chewable
Unknown Title
Multi-Vitamin With Fluoride Chewable Tablets
Rx Only
Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.
Other ingredients: Ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, FD&C yellow #6 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, orange flavor, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.
CLINICAL PHARMACOLOGYIt is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.
Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.
Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:
Ca10(PO4)6(OH)2 + 2F- —————> Ca10(PO4)6F2 + 2OH-
(Hydroxyapatite) (Fluorapatite)
Three stages of fluoride deposition in tooth enamel can be distinguished:
1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.
INDICATIONS AND USAGESupplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for caries prophylaxis.
See Dosage and Administration.
Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.
The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.
Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.
WARNINGSAs in the case of all medications, keep out of the reach of children.
Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.
PRECAUTIONSThe suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.
If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department. All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex. Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth. Fluoride supplements require long-term compliance on a daily basis. ADVERSE REACTIONSAllergic rash and other idiosyncrasies have been rarely reported.
DOSAGE AND ADMINISTRATION *1.0 ppm = 1 mg / liter **2.2 mg Sodium Fluoride contains 1mg fluoride ion. Fluoride Ion Level in Drinking Water (ppm)* AGE <0.3 ppm 0.3-0.6 ppm >0.6 ppm 4-6 years 0.50 mg / day**(2 tablets) 0.25 mg / day(1 tablet) None 6-16 years 1.0 mg / day(4 tablets) 0.50 mg / day(2 tablets) None HOW SUPPLIEDMulti-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.
Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.
Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].
Manufactured for: Boca Pharmacal, Inc.
Coral Springs, FL 33065 www.bocapharmacal.com
1-800-354-8460 Iss. 08/11
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL[Rev 18]
MULTI-VITAMIN WITH FLUORIDE
vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, .alpha.-tocopherol-acetate-dl, cyanocobalamin tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64376-813 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (VITAMIN A) VITAMIN A 2500 [iU] VITAMIN D (VITAMIN D) VITAMIN D 400 [iU] THIAMINE (THIAMINE) THIAMINE 1.05 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg NIACIN (NIACIN) NIACIN 13.5 mg PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 1.05 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 0.25 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU] CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug Inactive Ingredients Ingredient Name Strength MALTODEXTRIN CHOLECALCIFEROL CYANOCOBALAMIN FD&C YELLOW NO. 6 FOLIC ACID GELATIN MEDIUM-CHAIN TRIGLYCERIDES MAGNESIUM STEARATE MANNITOL NIACINAMIDE POVIDONE .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL, DL- RIBOFLAVIN SILICON DIOXIDE CITRIC ACID MONOHYDRATE THIAMINE VITAMIN A ACETATE ASCORBIC ACID GLYCERYL MONOSTEARATE BUTYLATED HYDROXYTOLUENE SUCROSE PYRIDOXINE SODIUM ASCORBATE SODIUM CITRATE STARCH, CORN SUCRALOSE ORANGE CELLULOSE, MICROCRYSTALLINE Product Characteristics Color ORANGE Score no score Shape ROUND (Flat) Size 13mm Flavor ORANGE Imprint Code BP;813 Contains Packaging # NDC Package Description Multilevel Packaging 1 64376-813-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/28/2011
Labeler - Boca Pharmacal, Inc (170266089) Registrant - Boca Pharmacal, Inc (170266089) Establishment Name Address ID/FEI Operations Cispharma, Inc 833171445 MANUFACTURE Revised: 01/2012Boca Pharmacal, Inc
MultiVit with Fluoride Chewable Tablets
Dosage Form: chewable tablets
Multi-Vitamin With Fluoride Chewable Tablets
Rx Only
*Daily Value not established
Supplement Facts
Serving Size: 1 Chewable Tablet
Amount Per Tablet
% Daily Value Adults & children 4 years or more
Vitamin A ................................. 2500 IU
50%
Vitamin C ................................... 60 mg
100%
Vitamin D .................................. 400 IU
100%
Vitamin E .................................... 15 IU
50%
Thiamin (B1) .......................... 1.05 mg
70%
Riboflavin (B2) ......................... 1.2 mg
71%
Niacin ..................................... 13.5 mg
68%
Vitamin (B6) ........................... 1.05 mg
53%
Folate ........................................ 0.3 mg
75%
Vitamin B12 ............................ 4.5 mcg
75%
Fluoride (as sodium fluoride) ... 1.0 mg
*
Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.
Other ingredients: Artificial grape flavor, ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, D&C Red # 7 calcium lake, FD&C Blue #1 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.
CLINICAL PHARMACOLOGYIt is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.
Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.
Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:
Ca10(PO4)6(OH)2 + 2F- —————> Ca10(PO4)6F2 + 2OH-
(Hydroxyapatite) (Fluorapatite)
Three stages of fluoride deposition in tooth enamel can be distinguished:
1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.
INDICATIONS AND USAGESupplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for caries prophylaxis.
See Dosage and Administration.
Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.
The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.
Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.
WARNINGSAs in the case of all medications, keep out of the reach of children.
Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.
PRECAUTIONSThe suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.
If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department. All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex. Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth. Fluoride supplements require long-term compliance on a daily basis. ADVERSE REACTIONSAllergic rash and other idiosyncrasies have been rarely reported.
DOSAGE AND ADMINISTRATION *1.0 ppm = 1 mg / liter **2.2 mg Sodium Fluoride contains 1mg fluoride ion. Fluoride Ion Level in Drinking Water (ppm)* AGE <0.3 ppm 0.3-0.6 ppm >0.6 ppm 4-6 years 0.50 mg / day**(1/2 tablet) 0.25 mg / day
(1/4 tablet) None 6-16 years 1.0 mg / day
(1 tablet) 0.50 mg / day
(1/2 tablet) None HOW SUPPLIED
Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.
Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.
Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].
Manufactured for:
Boca Pharmacal, Inc.
Coral Springs, FL 33065
www.bocapharmacal.com
1-800-354-8460 Iss. 07/11
[Rev 13]
MULTI-VITAMIN
vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, alpha-tocopherol-acetate-dl, cyanocobalamin tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64376-815 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (VITAMIN A) VITAMIN A 2500 [iU] VITAMIN D (VITAMIN D) VITAMIN D 400 [iU] THIAMINE (THIAMINE) THIAMINE 1.05 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg NIACIN (NIACIN) NIACIN 13.5 mg PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 1.05 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 1.0 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU] CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug Inactive Ingredients Ingredient Name Strength SODIUM CITRATE CHOLECALCIFEROL CYANOCOBALAMIN FD&C BLUE NO. 1 FOLIC ACID GELATIN STARCH, CORN MAGNESIUM STEARATE MANNITOL NIACINAMIDE POVIDONE PYRIDOXINE GRAPE RIBOFLAVIN SILICON DIOXIDE SODIUM ASCORBATE THIAMINE VITAMIN A ACETATE ALPHA-TOCOPHEROL ACETATE D&C RED NO. 7 ASCORBIC ACID SUCRALOSE BUTYLATED HYDROXYTOLUENE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL, DL- MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES SUCROSE GLYCERYL MONOSTEARATE METHYLCELLULOSE (1500 CPS) Product Characteristics Color PURPLE Score no score Shape ROUND (Biconvex) Size 13mm Flavor GRAPE Imprint Code BP;815 Contains Packaging # NDC Package Description Multilevel Packaging 1 64376-815-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/06/2011
Labeler - Boca Pharmacal, Inc (170266089) Registrant - Boca Pharmacal, Inc (170266089) Establishment Name Address ID/FEI Operations Cispharma, Inc 833171445 MANUFACTURE Revised: 09/2011Boca Pharmacal, Inc
Kids Choice
Dosage Form: gel, dentifrice
ACTIVE INGREDIENT
Active Ingredient: Stannous Fluoride
INACTIVE INGREDIENTSGlycerine, Hydroxy Ethyl Celluulose, Xylitol
Aids in the prevention of dental decay.
KEEP OUT OF REACH OF CHILDRENKEEP OUT OF REACH OF CHILDREN
DIRECTIONS FOR USEAdults and Children 12 years and Older: Use after regular brushing and flossing. Place gel across length of toothbrush. Brush Thoroughly. Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out). Do not swallow. Use once a day for cavity prevention. Supervise children until capable of using without supervision.
Children 6-11 Years: See directions above. Adult supervision required.
Children Under 6: Consult a Dentist or Physician.
This is a fluoride prevention treatment gel, not a toothpaste. Read directions carefully before use. This product may produce surface discoloration of the teeth. Adequate toothbrushing may prevent discoloration. Discoloration is not harmful or permanent and may be removed by a dental professional. Do not freeze or expose to extreme heat.
QUESTIONS ? COMMENTS ?Questions?? Comments??
Call 1-479-787-5168 M-F 9am to 5pm CST
If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.
PACKAGE LABELBrush on Therapy for Cavity Prevention - Doctor's Choice 0.4% Stannous Fluoride Gel
Manufactured by Massco Dental
Kids Choice
stannous fluoride gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-005 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .45103 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) XYLITOL Product Characteristics Color Score Shape Size Flavor BUBBLE GUM (BUBBLE GUM) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-005-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice
stannous fluoride gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-006 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) XYLITOL Product Characteristics Color Score Shape Size Flavor CREME DE MENTHE (HINT OF MINT) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-006-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice
stannous fluoride gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-007 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) XYLITOL Product Characteristics Color Score Shape Size Flavor LIME (LIMEAIDE) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-007-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice
stannous fluoride gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-008 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) XYLITOL Product Characteristics Color Score Shape Size Flavor GRAPE (GRAPE) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-008-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice
stannous fluoride gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-009 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) XYLITOL Product Characteristics Color Score Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-009-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice
stannous fluoride gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-015 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) XYLITOL Product Characteristics Color Score Shape Size Flavor COTTON CANDY (COTTON CANDY) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-015-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Operations Massco Dental A Division of Dunacin Pharmaceuticals 008081858 manufacture Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals
More Kids Choice resources Kids Choice Use in Pregnancy & Breastfeeding Kids Choice Support Group 3 Reviews for Kids Choice - Add your own review/rating Compare Kids Choice with other medications Prevention of Dental Caries
Gingimed
Dosage Form: oral liquid
ACTIVE INGREDIENT
STANNOUS FLUORIDE
GLYCERIN, FLAVOR,XYLITOL
APPROVED USES: RELIEF OF DENTINAL HYPERSENSITIVITY. CONTROL OF PERIO INFECTION.
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS FOR USEADULTS AND CHILDREN 6 YEARS AND OLDER: RINSE EACH DAY AFTER USUAL BRUSHING AND FLOSSING OR MORE OFTEN IF YOUR DENTIST RECOMMENDS ADDITIONAL THERAPY BASED ON THE DIAGNOSIS. PUSH DOWN ON PUMP TWICE OR POUR THE CONCENTRATED RINSE TO THE 1/8 FL. OX. MARK ON THE MIXING VIAL. ADD WATER TO THE 1 OZ. LINE. CLOSE TIGHTLY WITH SNAP-ON CAP AND SHAKE WELL. THIS PREPARES A 0.1% STANNOUS FLUORIDE RINSE. RINSE WITH ONE HALF OF THE SOLUTION FOR ONE MINUTE, EXPECTORATE (SPIT) AND REPEAT THE PROCEDURE WITH THE REMAINING HALF OF THE MIXTURE. DO NOT SWALLOW AND DO NOT RINSE MOUTH. RINSE MIXING VIAL WITH WATER AFTER EACH USE.
CHILDREN 6-12 YEARS: INSTRUCT AND SUPERVISE IN GOOD RINSING HABITS. (HELP TO MINIMIZE SWALLOWING)
CHILDREN UNDER 6: CONSULT A DENTIST.
FOR HOME IRRIGATION: PREPARE 1 OZ. OF Gingimed RINSE AS DESCRIBED ABOVE. POUR INTO IRRIGATOR RESIVOIR AND ADD 4 OZ. OF WATER. MIX THOROUGHLY. USE IRRIGATOR AS DESCRIBED
THIS PRODUCT MAY CAUSE MINIMAL SURFACE DISCOLORATION ON THE TEETH, MAY BE PREVENTED BY ADEQUATE BRUSHING.
IF MORE THAN AMOUNT DIRECTED FOR RINSING IS ACCIDENTALLY SWALLOWED, SEEK MEDICAL HELP FROM A POISON CONTROL CENTER. DO NOT USE BEFORE MIXING WITH WATER. USE AS DIRECTED BY A DENTAL PROFESSIONAL. THIS IS A FLUORIDE TREATMENT RINSE, NOT A MOUTHWASH.
ALCOHOL FREE PERIO TREATMENT. Gingimed 0.63% STANNOUS FLUORIDE READ DIRECTIONS THOROUGHLY. MIX WITH WATER BEFORE USE. NOW CONTAINING XYLITOL
MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE, AR (479) 787-5168 WWW.MASSCODENTAL.NET
Gingimed
stannous fluoride liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-210 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .71034 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN XYLITOL Product Characteristics Color Score Shape Size Flavor SPEARMINT (MINT) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-210-06 120 g In 1 BOTTLE, WITH APPLICATOR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Gingimed
stannous fluoride liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-211 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .71034 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN XYLITOL Product Characteristics Color Score Shape Size Flavor GRAPE (CARIBBEAN ICE) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-211-06 120 g In 1 BOTTLE, WITH APPLICATOR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Gingimed
stannous fluoride liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-212 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .71034 g in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN XYLITOL Product Characteristics Color Score Shape Size Flavor CINNAMON (CINNAMON) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 63783-212-06 120 g In 1 BOTTLE, WITH APPLICATOR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Operations Massco Dental A Division of Dunacin Pharmaceuticals 008081858 manufacture Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals
More Gingimed resources Gingimed Use in Pregnancy & Breastfeeding Gingimed Support Group 3 Reviews for Gingimed - Add your own review/rating Compare Gingimed with other medications Prevention of Dental Caries
Fluorishield
Dosage Form: dental gel
UNFLAVORED Fluorishield BRAND OF 1.1% Sodium Fluoride Dental Gel
Your dentist has selected for you Fluorishield, a 1.1% Sodium Fluoride product that was specially developed to prevent tooth decay which can occur from xerostomia (dry mouth). Dry mouth can result from radiation therapy, systemic diseases, medications which affect the salivary glands and mouth breathing. Clinical trials have shown that application of topical fluoride gel in the presence of good oral hygiene can prevent or significantly reduce tooth decay which is related to dry mouth. Fluorishield topical fluoride gel can be applied with a custom carrier or tray, directly brushed on, or used with an over denture. Your dentist will prescribe the method that is best suited for your individual needs. The gel is easily dispensed when the bottle is inverted for storing.
STORE INVERTED FOR EASY REMOVAL OF CONTENTS.
Description:Topical neutral 1.1% sodium fluoride for use as a dental caries preventative in children and adults. This prescription product is not a dentifrice.
Warnings:DO NOT SWALLOW. As with all medications, this product should be kept out of reach of children.
Overdose:Accidental ingestion of a usual treatment dose (1-2mgF) is not harmful.
Store at temperature between 68?-77?F (20?-25?C).
CAUTION:Federal (U.S.A.) law prohibits dispensing without a prescription.
INSTRUCTIONS Custom Carriers or TraysBrush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Add one drop of Fluorishield into each tooth area in the custom carrier and spread evenly with the applicator tip of the fluoride bottle. Place carriers over the teeth and let it remain in place for one (1) minute or longer (as directed by your doctor). Expectorate the excess gel. Clean carriers with cold water. Spit out the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.
Brush OnBrush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Apply a thin ribbon of gel to the toothbrush and spread evenly with the applicator tip of the fluoride bottle. Brush all tooth surfaces and allow fluoride to remain in place for one (1) minute or longer (as directed by your doctor). Clean carriers with cold water. Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.
OverdenturesBrush all tooth surfaces. Clean your dentures. Adults and children 6 years of age or older: Apply one (1) or two (2)drops of Fluorishield to each tooth area in your denture and place the dentures in your mouth. Leave in place for one (1) minute or longer (as directed by your doctor).Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.
™
MEDICAL PRODUCTS LABORATORIES, INC.
9990 Global Road • Phila., PA 19115-1083 800-523-0191 fax 215-677-7736 www.mplusa.com
Fluorishield
sodium fluoride gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10733-130 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 11 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER SACCHARIN SODIUM HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 10733-130-04 66 BOTTLE In 1 CARTON contains a BOTTLE 1 114 g In 1 BOTTLE This package is contained within the CARTON (10733-130-04)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 11/29/2009
Labeler - Medical Products Laboratories, Inc. (002290302) Revised: 02/2011Medical Products Laboratories, Inc.
More Fluorishield resources Fluorishield Use in Pregnancy & Breastfeeding Fluorishield Support Group 3 Reviews for Fluorishield - Add your own review/rating Compare Fluorishield with other medications Prevention of Dental Caries
Luborant
1. Name Of The Medicinal Product
Luborant.
2. Qualitative And Quantitative CompositionEach 0.8ml contains 0.003mg of Sodium Fluoride BP
Nipasept Sodium 1.600mg per 0.8 ml contains mixture of sodium hydroxybenzoates which is comprised of sodium p-hydroxybenzoate max. 0.064mg, Sodium Methyl 4-Hydroxybenzoate (E 219) 1.088mg to 1.216mg per 0.8 ml; Sodium Ethyl 4-hydroxybenzoate (E 215) 0.208mg to 0.288mg per 0.8 ml and Sodium Propyl 4-hydroxybenzoate (E 217) 0.128mg to 0.208mg.
3. Pharmaceutical FormOromucosal solution.
Pink viscous liquid with as odour of orange.
4. Clinical Particulars 4.1 Therapeutic IndicationsSaliva deficiency. Luborant is a saliva substitute for the management of conditions involving dryness of the mouth. These include xerostomia following radiotherapy or during treatment with antidepressants or anxiolytics, and other conditions involving a decrease in production of saliva, such as Sjogren's disease.
4.2 Posology And Method Of AdministrationLuborant is for oral use.
Adults, including the elderly: Two or three single applications orally up to four times daily or as directed by the physician. The average dose per application is 0.8ml of the product.
4.3 ContraindicationsHypersensitivity to sodium fluoride.
4.4 Special Warnings And Precautions For UseMottling of dental enamel has occurred in association with use of Sodium Fluoride in larger amounts than those contained in the dosage recommended for Luborant.
Do not exceed the stated dose.
The contents should be discarded if not used before a date one month after the date of opening.
4.5 Interaction With Other Medicinal Products And Other Forms Of InteractionNone known.
4.6 Pregnancy And LactationThere is no known or perceived hazard for use in pregnancy or lactation at the dosage recommended.
4.7 Effects On Ability To Drive And Use MachinesNone.
4.8 Undesirable EffectsNone stated
4.9 OverdoseThere are no reports of overdose. Serious symptoms are unlikely following acute overdosage.
5. Pharmacological Properties 5.1 Pharmacodynamic PropertiesPotassium Chloride
]
Salts normally found in saliva Electrolyte concentration close to whole saliva. No precise pharmacological activity other than electrolyte replacement in oral cavity.
Magnesium Chloride
]
hexahydrate
Calcium Chloride dihydrate
]
Potassium Phosphate Dibasic
]
Potassium Phosphate Monobasic
]
Sodium fluoride: used for the prophylaxis of dental caries, it renders the dentine and enamel of the teeth more resistant to acid.
5.2 Pharmacokinetic PropertiesLuborant is applied topically to the oral mucous membrane for its local effects within the oral cavity. Although the individual constituent salts may undergo gastro-intestinal absorption, their concentration in daily dosage recommended for Luborant represents only a small percentage pf the recommended daily human requirements of these salts and can not, therefore, be expected to influence normal fluid or electrolyte balance.
5.3 Preclinical Safety DataNo further relevant information other than that which is included in other sections of the Summary of Product Characteristics.
6. Pharmaceutical Particulars 6.1 List Of ExcipientsPotassium Chloride
Magnesium Chloride hexahydrate
Calcium Chloride dihydrate
Potassium Phosphate Dibasic
Potassium Phosphate Monobasic
Nipasept Sodium
Sorbitol solution 70% Non-crystallizing
Sodium carboxymethyl cellulose
Orange Flavour IFF VX 1997
Carmoisine Red CI 14720 E122
Hydrochloric Acid
Purified Water
6.2 IncompatibilitiesNone known.
6.3 Shelf LifeUnopened : 2 years
Opened : 1 month
6.4 Special Precautions For StorageKeep in outer carton.
Do not store above 25°C.
6.5 Nature And Contents Of Container60ml, high density polyethylene bottle with a pump action applicator packed in cardboard cartons to contain 1 x 60ml and 6 x 60ml bottles.
6.6 Special Precautions For Disposal And Other HandlingContents to be discarded if not used before a date one month after the date of opening.
7. Marketing Authorisation HolderGoldshield Pharmaceuticals Limited,
NLA Tower, 12-16 Addiscombe road,
Croydon,
Surrey,
CR0 0XT,
United Kingdom
8. Marketing Authorisation Number(S)PL 12762/0227
9. Date Of First Authorisation/Renewal Of The Authorisation10th January 1990/24th February 1999
10. Date Of Revision Of The TextDecember 2009
Prevident 5000 Sensitive
sodium fluoride and potassium nitrate gel
Dosage Form: gel, dentifrice
Colgate®
PreviDent®5000 ppm
SENSITIVE
Rx ONLY
1.1% Sodium Fluoride, 5% Potassium Nitrate
Prescription Strength Toothpaste for Sensitive Teeth
Prevident 5000 Sensitive DescriptionSelf-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.
Active IngredientsSodium fluoride 1.1% (w/w), Potassium nitrate 5%
Inactive Ingredientswater, hydrated silica, sorbitol, PEG-12, carrageenan, sodium lauryl sulfate, flavor, poloxamer 407, cocamidopropyl betaine, sodium saccharin, mica, sodium hydroxide, titanium dioxide, D&C yellow no. 10, FD&C blue no. 1
Prevident 5000 Sensitive - Clinical PharmacologyFrequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.
Indications and Usage for Prevident 5000 SensitiveA dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 PreviDent® 5000 Sensitive brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
ContraindicationsDo not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
WarningsNot for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician.
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Precautions GeneralNot for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of FertilityIn a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy Teratogenic Effects Pregnancy Category BIt has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.
Nursing MothersIt is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.
Pediatric UseSafety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
Geriatric UseOf the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5
Adverse ReactionsAllergic reactions and other idiosyncrasies have been rarely reported.
OverdosageAccidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 Sensitive contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.
Prevident 5000 Sensitive Dosage and AdministrationFollow these instructions unless otherwise instructed by your dental professional:
Adults and children 12 years of age and older: Apply at least 1 inch strip of PreviDent® 5000 Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician. How is Prevident 5000 Sensitive Supplied3.4 FL OZ (100 mL) in plastic bottles. Mild Mint: NDC 0126-0070-61
STORAGEStore at Controlled Room Temperature, 68-77°F (20-25°C)
REFERENCES American Dental Association, Accepted Dental Therapeutics Ed. 40 (Chicago, 1984): 405-407. H.R. Englander et al., JADA 75 (1967): 638-644. H.R. Englander et al., JADA 78 (1969): 783-787. H.R. Englander et al., JADA 83 (1971): 354-358. Data on file, Colgate Oral Pharmaceuticals.Questions? Comments? Please Call 1-800-962-2345
www.colgateprofessional.com
NDC 0126-0070-61
Colgate®
PreviDent®
5000ppm
SENSITIVE
1.1% Sodium Fluoride
5% Potassium Nitrate
PRESCRIPTION STRENGTH
TOOTHPASTE FOR SENSITIVE TEETH
MILD MINT
3.4 FL OZ (100 mL)
Rx ONLY
P10000587
PREVIDENT 5000 SENSITIVE
sodium fluoride gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0126-0070 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (fluoride ion) Sodium fluoride 12.7 mg in 1 mL Potassium nitrate (Potassium cation) Potassium nitrate 57.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color GREEN Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 0126-0070-61 100 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 07/06/2009
Labeler - Colgate-Palmolive Company (055002195) Revised: 07/2009Colgate-Palmolive Company More Prevident 5000 Sensitive resources Prevident 5000 Sensitive Side Effects (in more detail) Prevident 5000 Sensitive Use in Pregnancy & Breastfeeding 0 Reviews for Prevident 5000 Sensitive - Add your own review/rating Prevident 5000 Sensitive Concise Consumer Information (Cerner Multum) APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer) Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer) PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer) Compare Prevident 5000 Sensitive with other medications Prevention of Dental Caries
Sodium Fluoride F 18 Injection
Dosage Form: injection, solution
FULL PRESCRIBING INFORMATION
Indications and Usage for Sodium Fluoride F 18 Injection
Sodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.
Sodium Fluoride F 18 Injection Dosage and Administration Radiation Safety - Drug Handling Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection. The dose of Sodium Fluoride F 18 Injection should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed. The final dose for the patient should be calculated using proper decay factors from the time of EOS, and measured by a suitable radioactivity calibration system before administration [Description(11.2)]. Radiation Safety - Patient Preparation To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F 18 Injection. Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection and as frequently thereafter as possible for the next 12 hours. Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose. Inspect Sodium Fluoride F 18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer Sodium Fluoride F 18 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Aseptically withdraw Sodium Fluoride F 18 Injection from its container. Recommended Dose for AdultsAdminister 300–450 MBq (8–12 mCi) as an intravenous injection.
Recommended Dose for Pediatric PatientsIn reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq– 148 MBq (0.5 mCi- 4 mCi) were used.
Radiation DosimetryThe age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection are shown in Table 1. These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission [1] and the International Commission on Radiological Protection for Sodium Fluoride Injection [2]. The bone, bone marrow and urinary bladder are considered target and critical organs.
Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection Estimated Radiation Dose mGy/MBq Organ Adult70 kg* 15 year
56.8 kg† 10 year
33.2 kg† 5 year
19.8 kg† 1 year
9.7 kg† * Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996. † Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals (), Ann ICRP, Volume 18, , pages15 and 74, 1987 Adrenals 0.0062 0.012 0.018 0.028 0.052 Brain 0.0056 N/A N/A N/A N/A Bone surfaces 0.060 0.050 0.079 0.13 0.30 Breasts 0.0028 0.0061 0.0097 0.015 0.030 Gallbladder wall 0.0044 N/A N/A N/A N/A Stomach wall 0.0038 0.008 0.013 0.019 0.036 Small intestine 0.0066 0.012 0.018 0.028 0.052 Upper large intestine wall 0.0058 0.010 0.016 0.026 0.046 Lower large intestine wall 0.012 0.016 0.025 0.037 0.063 Heart wall 0.0039 N/A N/A N/A N/A Kidneys 0.019 0.025 0.036 0.053 0.097 Liver 0.0040 0.0084 0.013 0.021 0.039 Lungs 0.0041 0.0084 0.013 0.020 0.039 Muscle 0.0060 N/A N/A N/A N/A Ovaries 0.011 0.016 0.023 0.036 0.063 Pancreas 0.0048 0.0096 0.015 0.023 0.044 Red marrow 0.028 0.053 0.088 0.18 0.38 Skin 0.0040 N/A N/A N/A N/A Spleen 0.0042 0.0088 0.014 0.021 0.041 Testes 0.0078 0.013 0.021 0.033 0.062 Thymus 0.0035 N/A N/A N/A N/A Thyroid 0.0044 0.0084 0.013 0.020 0.036 Urinary bladder wall 0.25 0.27 0.4 0.61 1.1 Uterus 0.019 0.023 0.037 0.057 0.099 Other tissue N/A 0.010 0.015 0.024 0.044 Effective Dose
Equivalent mSv/MBq 0.027 0.034 0.052 0.086 0.17 Imaging Guidelines Imaging of Sodium Fluoride F 18 Injection can begin 1–2 hours after administration; optimally at 1 hour post administration. Encourage the patient to void immediately prior to imaging the fluoride F18 radioactivity in the lumbar spine or bony pelvis. Dosage Forms and Strengths
Multiple-dose vial containing 370 - 7,400 MBq/mL (10 - 200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.
ContraindicationsNone.
Warnings and Precautions Allergic ReactionsAs with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available.
Radiation RisksSodium Fluoride F 18 Injection may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F18 injection have not been performed. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration(2.1)].
Adverse ReactionsNo adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.
Drug InteractionsThe possibility of interactions of Sodium Fluoride F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.
USE IN SPECIFIC POPULATIONS PregnancyPregnancy Category C
Any radiopharmaceutical including Sodium Fluoride F18 Injection has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. Animal reproduction studies have not been conducted with Sodium Fluoride F 18 Injection. Prior to the administration of Sodium Fluoride F 18 Injection to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F 18 Injection should be given to a pregnant woman only if clearly needed.
It is not known whether Sodium Fluoride F 18 Injection is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of Sodium Fluoride F 18 Injection or not to administer Sodium Fluoride F 18 Injection, taking into account the importance of the drug to the mother. The body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours (10 half-lives). To minimize the risks to a nursing infant, interrupt nursing for at least 24 hours.
Pediatric UseIn reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq – 148 MBq (0.5 mCi - 4 mCi) were used. Sodium Fluoride F18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F18 injection.
Sodium Fluoride F 18 Injection Description Chemical CharacteristicsSodium Fluoride F 18 Injection is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F18, has the molecular formula Na[18F] with a molecular weight of 40.99, and has the following chemical structure:
Sodium Fluoride F 18 Injection is provided as a ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370 MBq and 7,400 MBq (10 mCi to 200 mCi) sodium fluoride F18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in XX mL multiple- dose glass vials with variable total volume and total radioactivity in each vial.
Physical CharacteristicsFluoride F18 decays by positron (?+) emission and has a half-life of 109.7 minutes. Ninety-seven percent of the decay results in emission of a positron with a maximum energy of 633 keV and 3% of the decay results in electron capture with subsequent emission of characteristic X-rays of oxygen. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 2). Fluorine F18 atom decays to stable 18O-oxygen.
Table 2: Principal Emission Data for Fluoride F18 Radiation/Emission % per Disintegration Mean Energy * Produced by positron annihilation[3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981. Positron (?+) 96.73 249.8 keV Gamma (±)* 193.46 511.0 keV
The specific gamma ray constant (point source air kerma coefficient) for fluoride F18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). A range of values for the attenuation of radiation results from the interposition of various thickness of Pb. The range of attenuation coefficients for this radionuclide is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb with a coefficient of attenuation of 0.25 will decrease the external radiation by 75%.
Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0 0.00 4 0.50 8 0.25 13 0.10 26 0.01 39 0.001 52 0.0001Table 4 lists the fraction of radioactivity remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.
Table 4: Physical Decay Chart for Fluoride F18 Time Since Calibration Fraction Remaining * Calibration time 0* 1.00 15 minutes 0.909 30 minutes 0.826 60 minutes 0.683 110 minutes 0.500 220 minutes 0.250 440 minutes 0.060 12 hours 0.011 24 hours 0.0001 Sodium Fluoride F 18 Injection - Clinical Pharmacology Mechanism of ActionFluoride F18 ion normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones.
PharmacodynamicsIncreased fluoride F18 ion deposition in bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of bone.
PharmacokineticsAfter intravenous administration, fluoride F18 ion is rapidly cleared from the plasma in a biexponential manner. The first phase has a half-life of 0.4 h, and the second phase has a half-life of 2.6 h. Essentially all the fluoride F18 that is delivered to bone by the blood is retained in the bone. One hour after administration of fluoride F18 only about 10% of the injected dose remains in the blood. Fluoride F18 diffuses through capillaries into bone extracellular fluid space, where it becomes bound by chemisorption at the surface of bone crystals, preferentially at sites of newly mineralizing bone.
Deposition of fluoride F18 in bone appears to be primarily a function of blood flow to the bone and the efficiency of the bone in extracting the fluoride F18. Fluoride F18 does not appear to be bound to serum proteins.
In patients with normal renal function, 20% or more of the fluorine ion is cleared from the body in the urine within the first 2 hours after intravenous administration.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of FertilityStudies to assess reproductive toxicity, mutagenesis and carcinogenesis potential of Sodium Fluoride F 18 Injection have not been performed.
Clinical Studies Metastatic Bone DiseaseThe doses used in reported studies ranged from 2.7 mCi to 20 mCi (100 MBq to 740 MBq), with an average median dose of 10 mCi (370 MBq) and an average mean dose of 9.2 mCi (340 MBq). In PET imaging of bone metastases with Sodium Fluoride F 18 Injection, focally increased tracer uptake is seen in both osteolytic and osteoblastic bone lesions. Negative PET imaging results with Sodium Fluoride F 18 Injection do not preclude the diagnosis of bone metastases. Also, as benign bone lesions are also detected by Sodium Fluoride F 18 Injection, positive PET imaging results cannot replace biopsy to confirm a diagnosis of cancer.
Other Bone DisordersThe doses used in reported studies ranged from 2.43 mCi to 15 mCi (90 MBq to 555 MBq), with an average median dose of 8.0 mCi (300 MBq) and an average mean dose of 7.6 mCi (280 MBq).
REFERENCES Stabin, M.G., Stubbs, J.B. and Toohey R.E.,Radiation Dose Estimates for Radiopharmaceuticals,U.S. Nuclear Regulatory Commission report NUREG/CR-6345, page 10, 1996. Radiation Dose to Patients from Radiopharmaceuticals,ICRP publication 53, Ann ICRP, 18 pages 15 and 74, 1987. Kocher, D.C., "Radioactive Decay Data Tables: A Handbook of decay data for application to radiation dosimetry and radiological assessments" DOE/TIC-11026, page 69, 1981. How is Sodium Fluoride F 18 Injection SuppliedSodium Fluoride F 18 Injection is supplied in a multiple-dose Type I glass vial with (elastomeric) stopper and aluminum crimp seal containing between 370 and 7,400 MBq/mL (10 - 200 mCi/mL) of no-carrier-added sodium fluoride F18, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume and total radioactivity per vial are variable. Each vial is enclosed in a shielding container of appropriate thickness.
The product is available in a 30 mL vial configuration with a variable fill volume. The NDC number is:
49609-102-01 (30 mL)
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Use the solution within 12 hours of the EOS reference time.
HandlingReceipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.
Patient Counseling Information Pre-study HydrationEncourage patients to drink at least 500 mL of water prior to drug administration.
Post-study VoidingTo help protect themselves and others in their environment, patients should take the following precautions for 12 hours after injection: whenever possible, use a toilet and flush several times after each use; wash hands thoroughly after each voiding or fecal elimination. If blood, urine or feces soil clothing, wash the clothing separately.
Manufactured by:IBA Molecular North America Inc.
21000 Atlantic Boulevard, Suite 730
Dulles, Virginia, 20166, USA
Distributed by: IBA Molecular North America Inc.
21000 Atlantic Boulevard, Suite 730
Dulles, Virginia, 20166, USA
PRINCIPAL DISPLAY PANEL - 30 mL Vial Label
Sodium Fluoride F18 Injection
10-200 mCi/mL at end of synthesis (EOS)
Diagnostic – for intravenous use only.
Sterile, Non-pyrogenic
Batch #: __________________________
EOS date: ________ EOS time: _______
EOS activity: ________mCi Vol: _____mL
Concentration: ____________ mCi/mL
Exp. date: _______ Exp time: ________
NDC# 49609-102-01
Each mL contains 0.37 to 7.4 GBq (10-
200 mCi) of no carrier added Sodium
[18F] Fluoride in aqueous 0.9% sodium
chloride solution at EOS.
Use within 12 hours of EOS.
30 mL Multiple Dose Vial
Store at 25°C (77°F); excursions permitted
to 15 – 30°C (59-86°F) [see USP controlled
room temperature].
Store upright in shielded container.
Aseptically withdraw and handle doses.
Do not use if cloudy or contains particulate matter.
Calculate correct dosage from date and time of calibration
Caution: Radioactive Material RX only
Manufactured by IBA Molecular North America Inc. Dulles VA, 20166
18F half life = 109.7 min
SODIUM FLUORIDE F 18
sodium fluoride f-18 injection Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49609-102 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE F-18 (FLUORIDE ION F-18) SODIUM FLUORIDE F-18 200 mCi in 1 mL Inactive Ingredients Ingredient Name Strength Sodium Chloride 9 mg in 1 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 49609-102-01 30 mL In 1 VIAL, MULTI-DOSE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/08/2011
Labeler - IBA Molecular North America, Inc. (005365149) Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 832625789 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 025600556 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 832599976 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 832625904 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 829109441 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 829824825 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 032324142 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 006320902 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 008017970 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Establishment Name Address ID/FEI Operations IBA Molecular North America, Inc. 808288356 POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION Revised: 12/2011IBA Molecular North America, Inc.
Heart and Circulation Tonic
Generic Name: crataegus fruit, arnica montana, potassium phosphate, dibasic and calcium fluoride granule
Dosage Form: FOR ANIMAL USE ONLY
HEART AND CIRCULATION TONIC
Improves circulation and strengthens heart and arteries
Indications: Homeopathic heart and circulation tonic.
Dosage: Sprinkle into the mouth and administer 3 times daily. Cats and dogs under 20 lbs: 1 large pinch. Dogs 20-50 lbs: 2 pinches. Dogs over 50 lbs: 1/4 cap.
Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.
Ingredients: Each dose contains equal parts of Crataegus (3X) (HPUS), Arnica (3X) (HPUS), Kali phos (6C) (HPUS), Calc flour (6C) (HPUS)
Sucrose (inactive ingredient).
Contains no gluten, artificial flavors, colors or preservatives.
All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, FL 33487
Phone: +1.877.289.1235
International: +1.561.999.8857
The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.
Keep this and all medicines from the reach of children.
HEART AND CIRCULATION TONIC
crataegus, arnica , kali phos, calc flour granule Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-156 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CRATAEGUS FRUIT (CRATAEGUS FRUIT) CRATAEGUS FRUIT 3 [hp_X] in 50 mg ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 3 [hp_X] in 50 mg POTASSIUM PHOSPHATE, DIBASIC (POTASSIUM CATION) POTASSIUM PHOSPHATE, DIBASIC 6 [hp_C] in 50 mg CALCIUM FLUORIDE (CALCIUM CATION) CALCIUM FLUORIDE 6 [hp_C] in 50 mg Inactive Ingredients Ingredient Name Strength SUCROSE 20000 mg in 20000 mg Product Characteristics Color white (white sucrose granules) Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 68647-156-10 20000 mg In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2010
Labeler - Feelgood Health (538418296) Establishment Name Address ID/FEI Operations W. Last 567284153 manufacture Revised: 09/2010Feelgood Health
Equine Joint Relief
Generic Name: homeopathic remedy
Dosage Form: FOR ANIMAL USE ONLY
Equine Joint Relief
For stiff joints and sore muscles
Indications: Homeopathic remedy for the relief of stiff joints and sore muscles in horses.
Dosage: Sprinkle 1 capful of pilules directly into the mouth or offer on the hand. Initial dose: every 30 minutes for up to 10 doses. Thereafter, 3 times daily.
Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines out of reach of children.
Ingredients: Apis (6C) (HPUS), Rhus tox (30C) (HPUS), Ferrum phos (6X) (HPUS), Nat phos (6X) (HPUS), Arnica (6C) (HPUS), Calc fluor (6X) (HPUS)
Sucrose (inactive ingredient).
Contains no gluten, artificial flavors, colors or preservatives.
All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, FL 33487
Phone: 1.877.289.1235
International: + 1.561.999.8857
The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.
Keep this and all medicines out of reach of children.
Equine Joint Relief
apis, rhus tox, ferrum phos , nat phos , arnica , calc fluor granule Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-187 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 6 [hp_C] in 33.3 mg TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 30 [hp_C] in 33.3 mg FERRUM PHOSPHORICUM (FERRUM PHOSPHORICUM) FERRUM PHOSPHORICUM 6 [hp_X] in 33.3 mg SODIUM PHOSPHATE, DIBASIC ANHYDROUS (SODIUM CATION) SODIUM PHOSPHATE, DIBASIC ANHYDROUS 6 [hp_X] in 33.3 mg ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 6 [hp_C] in 33.3 mg CALCIUM FLUORIDE (CALCIUM CATION) CALCIUM FLUORIDE 6 [hp_X] in 33.3 mg Inactive Ingredients Ingredient Name Strength SUCROSE Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 68647-187-10 200000 mg In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2010
Labeler - Feelgood Health (538418296) Establishment Name Address ID/FEI Operations W.Last 567284153 manufacture Revised: 09/2010Feelgood Health
PreviDent Rinse
Pronunciation: SO-dee-um FLOR-ide
Generic Name: Sodium Fluoride
Brand Name: Examples include Listermint and PreviDent
PreviDent Rinse is used for:
Preventing dental caries.
PreviDent Rinse is a fluoride rinse. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.
Do NOT use PreviDent Rinse if: you are allergic to any ingredient in PreviDent RinseContact your doctor or health care provider right away if any of these apply to you.
Before using PreviDent Rinse:Some medical conditions may interact with PreviDent Rinse. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substancesSome MEDICINES MAY INTERACT with PreviDent Rinse. However, no specific interactions with PreviDent Rinse are known at this time.
Ask your health care provider if PreviDent Rinse may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use PreviDent Rinse:Use PreviDent Rinse as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Use PreviDent Rinse at bedtime after brushing your teeth. Measure the prescribed dose and swish between your teeth for 1 minute, then spit out, unless directed otherwise by your doctor. Do not eat, drink, or rinse your mouth for 30 minutes after using PreviDent Rinse. If you miss a dose of PreviDent Rinse, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.Ask your health care provider any questions you may have about how to use PreviDent Rinse.
Important safety information: Do not exceed the dose recommended by your doctor or dentist. Notify your dentist if your teeth become spotted or stained. PreviDent Rinse is not recommended for use in CHILDREN younger than 6 years old; safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking PreviDent Rinse, contact your doctor. You will need to discuss the benefits and risks of using PreviDent Rinse while pregnant. It is not known if PreviDent Rinse is found in breast milk. If you are or will be breast-feeding while you are using PreviDent Rinse, check with your doctor. Discuss the risks to your baby. Possible side effects of PreviDent Rinse:All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with PreviDent Rinse. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: PreviDent side effects (in more detail)
If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; extreme thirst; increased drooling; muscle weakness; nausea; paleness of the skin; seizures; shallow, rapid breathing; shaking; stomach pain; vomiting; weak or fast heartbeat.
Proper storage of PreviDent Rinse:Store PreviDent Rinse at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep PreviDent Rinse out of the reach of children and away from pets.
General information: If you have any questions about PreviDent Rinse, please talk with your doctor, pharmacist, or other health care provider. PreviDent Rinse is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.This information is a summary only. It does not contain all information about PreviDent Rinse. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More PreviDent resources PreviDent Side Effects (in more detail) PreviDent Use in Pregnancy & Breastfeeding PreviDent Support Group 0 Reviews for PreviDent - Add your own review/rating Compare PreviDent with other medications Prevention of Dental CariesCholetec
Dosage Form: injection, powder, lyophilized, for solution
For Diagnostic Use
Choletec DescriptionEach reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF2•2H2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF2•2H2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture.
The pH of the reconstituted product is 4.2 to 5.7.
The structure of mebrofenin (2,2’-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below:
When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection.
PHYSICAL CHARACTERISTICSTechnetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging studies is listed in Table 1.
TABLE 1 Principal Radiation Emission Data Radiation Mean % perDisintegration Mean Energy
(keV) 1Kocher, David C., “Radioactive Decay Data Tables”, DOE/ TIC-11026, (1981) p.108. Gamma-2 89.07 140.5 External Radiation
The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.
TABLE 2 Radiation Attenuation by Lead Shielding Shield Thickness(Pb) cm Coefficient
of Attenuation 0.017 0.5 0.08 10-1 0.16 10-2 0.25 10-3 0.33 10-4
To correct for physical decay of technetium Tc 99m, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.
TABLE 3 Physical Decay Chart: Tc 99m half-life 6.02 hours Hours FractionRemaining Hours Fraction
Remaining *Calibration time 0* 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 18 0.126 Choletec - Clinical Pharmacology
Mebrofenin is an iminodiacetic acid (HIDA) derivative with no known pharmacologic action at the recommended doses.
Following intravenous administration in normal subjects, Technetium Tc 99m Mebrofenin was rapidly cleared from the circulation. The mean percent injected dose remaining in the blood at 10 minutes was 17%. The injected activity was cleared through the hepatobiliary system with visualization of the liver by 5 minutes and maximum liver uptake occurring at 11 minutes post-injection. Hepatic duct and gallbladder visualization occurred by 10 to 15 minutes and intestinal activity was visualized by 30 to 60 minutes in subjects with normal hepatobiliary function. The mean percent injected dose excreted in the urine during the first 3 hours was 1% (0.4 to 2.0%).
Elevated serum bilirubin levels increase renal excretion of Tc 99m HIDA agents. In two studies in which Tc 99m Mebrofenin was administered to patients having mean elevated serum bilirubin levels of 9.8 mg/dL (1.7 to 46.3 mg/dL), the mean percent injected dose excreted in the urine during the first 3 hours was 3% (0.2 to 11.5%). The mean percent injected dose excreted in the urine during 3-24 hours was 14.9% (0.4 to 34.8%).
In jaundiced patients, the percent injected dose remaining in the blood at 10 minutes may be twice as high or more than the level in normals. Hepatobiliary transit may be delayed and visualization times increased. As a consequence, the quality of the images obtained frequently diminishes.
Indications and Usage for CholetecTechnetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.
ContraindicationsHypersensitivity to this compound.
WarningsThe theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.
Precautions GeneralContents of the reaction vial are intended only for use in the preparation of Technetium Tc 99m Mebrofenin and are not to be administered directly to the patient.
Delayed or non-visualization of the gallbladder may occur in the immediate post-prandial period or after prolonged fasting or parenteral feeding. Functional biliary obstruction may accompany chronic cholecystitis or pancreatitis. In addition, patients with hepatocellular disease may show non-visualization or delayed visualization of the gallbladder. Delayed intestinal transit may also be noted in such patients. Juvenile hepatitis may be associated with gallbladder non-visualization and the failure to visualize activity in the intestine. Administration of meperidine or morphine may delay intestinal transit of the imaging agent and may result in nonvisualization. Septic patients may show absent or delayed hepatobiliary clearance. Thus, a positive finding does not of itself permit a differential diagnosis of any of the above conditions and should be evaluated in the light of the total clinical picture and results of other diagnostic modalities.
The components of the kit are supplied sterile and nonpyrogenic. Aseptic procedures normally employed in making additions and withdrawals from sterile, nonpyrogenic containers should be used during the addition of the pertechnetate solution and the withdrawal of doses for patient administration.
The Technetium Tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the reduced state. Any oxidant present in the sodium pertechnetate Tc 99m supply may, thus, adversely affect the quality of the radiopharmaceutical. Hence, sodium pertechnetate Tc 99m containing oxidants should not be employed.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.
As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers.
Tc 99m Mebrofenin should be formulated no more than 18 hours prior to clinical use.
Carcinogenesis, Mutagenesis, Impairment of FertilityNo long term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Mebrofenin may affect fertility in males or females.
Pregnancy Pregnancy Category CAnimal reproduction studies have not been conducted with Technetium Tc 99m Mebrofenin. It is also not known whether Technetium Tc 99m Mebrofenin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m Mebrofenin should be given to a pregnant woman only if the expected benefits to be gained clearly outweigh the potential hazards.
Nursing MothersTechnetium Tc 99m is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings.
Pediatric UseSafety and effectiveness in children below the age of 18 have not be established.
Adverse ReactionsUrticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.
Choletec Dosage and AdministrationThe suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is:
Nonjaundiced patient: 74-185 MBq (2-5 mCi) Patient with serumbilirubin level greater
than 1.5 mg/dL: 111-370 MBq (3-10 mCi)
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.
An interval of at least 24 hours should be allowed before repeat examination.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
RADIATION DOSIMETRYThe estimated absorbed radiation doses 1,2 to organs and tissues of an average subject (70 kg) from an intravenous injection of 370 MBq (10 millicuries) of Technetium Tc 99m Mebrofenin are shown in Table 4.
TABLE 4 Estimated Absorbed Radiation Doses† Normal Subjects* SeverelyJaundiced Patients** Tissue mGy/
370 MBq rads/
10 mCi mGy/
370 MBq rads/
10 mCi †Method of Calculation: (1) Loberg, M.D., Buddemeyer, E.V.: Application of pharmacokinetic modeling to the radiation dosimetry of hepatobiliary agents. In Third International Radiopharmaceutical Dosimetry Symposium, FDA No. 81-8166, U.S. Department of Health and Human Services, Public Health Service, FDA, Bureau of Radiological Health, Rockville, MD, (1981) pp. 318-332. (2) Values for S: “S”, Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975). * Bilirubin <1.5 mg/dL
Calculations assume that 98% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity. ** Bilirubin >10 mg/dL (mean 21.8 mg/dL)
Calculations assume that 66% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity. Total Body 2.0 0.2 1.7 0.17 Liver 4.7 0.47 8.1 0.81 Gallbladder Wall 13.7 1.37 12.5 1.25 Small Intestine 29.9 2.99 16.0 1.60 Upper Large Intestine Wall 47.4 4.74 24.8 2.48 Lower Large Intestine Wall 36.4 3.64 19.7 1.97 Kidney 2.2 0.22 1.9 0.19 Urinary Bladder Wall 2.9 0.29 24.2 2.42 Ovaries 10.1 1.01 6.4 0.64 Testes 0.5 0.05 1.1 0.11 Red Marrow 3.4 0.34 2.5 0.25 How is Choletec Supplied
Choletec (Kit for the Preparation of Technetium Tc 99m Mebrofenin) is supplied in kits of 10 reaction vials. Each vial contains a sterile, nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF2•2H2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF2•2H2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH has been adjusted with hydrochloric acid or sodium hydroxide prior to lyophilization. The lyophilized vial contents are sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7.
Kit Contents10 sterile multidose reaction vials.
20 pressure-sensitive labels for Technetium Tc 99m Mebrofenin.
1 package insert.
Preparation of Technetium Tc 99m Mebrofenin is done by the following aseptic procedure:
Waterproof gloves should be worn during the preparation procedure. Place reaction vial in an appropriate lead shield. Swab the rubber closure of the reaction vial with a germicide. Inject 1 to 5 mL sterile additive free sodium pertechnetate Tc 99m injection containing up to 3700 MBq (100 mCi) Tc 99m into the reaction vial. Be sure to maintain a nitrogen atmosphere in the vial by not introducing air during reconstitution.NOTE: If sodium pertechnetate Tc 99m injection must be diluted for use with Choletec (Kit for the preparation of Technetium Tc 99m Mebrofenin), only preservative free Sodium Chloride Injection USP should be used. Secure the lead shield cover. Swirl the vial gently to mix contents and let stand for 15 minutes. Record the date and time of preparation on pressure-sensitive label. Affix pressure-sensitive label to shield. Examine vial contents. If the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used. Measure the radioactivity by a suitable calibration system and record on the shield label prior to patient administration. Withdraw material with a sterile lead shielded syringe for use within 18 hours of preparation. Storage
Store the kit as supplied at 20-25°C (68-77°F) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.
The U.S. Nuclear Regulatory Commission has approved this reagent kit for distribution to persons licensed to use byproduct material identified in §35.200 of 10 CFR Part 35, to persons who hold an equivalent license issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.
Manufactured for
Bracco Diagnostics Inc.
Princeton, NJ 08543
by
Hollister-Stier LLC
Spokane, WA 99207
May 2007
875015-H01
Choletec
mebrofenin injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0270-0083 Route of Administration INTRAVENOUS DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength Mebrofenin (mebrofenin) Active 45 MILLIGRAM In 1 VIAL Stannous Fluoride Dihydrate Inactive 0.54 MILLIGRAM In 1 VIAL methylparaben Inactive 5.2 MILLIGRAM In 1 VIAL propylparaben Inactive 0.58 MILLIGRAM In 1 VIAL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 0270-0083-20 10 VIAL In 1 CARTON contains a VIAL 1 1 VIAL In 1 VIAL This package is contained within the CARTON (0270-0083-20)
Revised: 03/2008Bracco Diagnostics Inc. More Choletec resources Choletec Side Effects (in more detail) Choletec Support Group 0 Reviews · Be the first to review/rate this drug
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