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.

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

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• Prevention of Dental Caries