FLUORIDE DROPS

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.

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 1ozFluoritab 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

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