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Name:Fluoride Drops
Manufacturer:Fluoritab Corporation
Category:Prescription Marketed Drugs


FLUORITAB FLUORIDE DROPS 1 fluid ounce size

FLUORIDE DROPS   - sodium fluoride liquid 
Fluoritab Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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.

Fluoritab Fluoride Drops label back 1oz

Fluoritab Fluoride Drops label front 1oz


FLUORIDE DROPS  
sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
METHYLPARABEN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC: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: 05/2011 Fluoritab Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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