Fluoritab Fluoride Drops

Name: Fluoritab Fluoride 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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:0288-5523-01 30 mL in 1 BOTTLE, DROPPER
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: 05/2011   Fluoritab Corporation
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