F
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.
INACTIVE INGREDIENTS: WATER, PRESERVATIVE.
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
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Prevention of Dental Caries
Fluoritab Fluoride Drops
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