F
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 Trays
Brush 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 On
Brush 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.
Overdentures
Brush 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.
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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
Fluorishield
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