FDA Label for Fluoride Drops
View Indications, Usage & Precautions
Fluoride Drops Product Label
The following document was submitted to the FDA by the labeler of this product Fluoritab Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
CONTAINS: SODIUM FLUORIDE IN AN AQUEOUS VEHICLE WITH PRESERVATIVE.
EACH 8 DROPS EQUIVALENT TO 1 MG. F. (FROM 2.2 MG SODIUM FLUORIDE)
Dosage & Administration
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
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
CAUTION: FEDERAL (U.S.A.) LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.
Contraindications
CONTRAINDICATIONS: PATIENTS WITH MEDICAL CONDITION OF DENTAL FLUOROSIS.
Otc - Purpose
PRODUCT CATEGORY: DENTAL CARIES PROPHYLACTIC, NUTRITIONAL SUPPLEMENT (MINERAL)
Indications & Usage
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 Ingredient
INACTIVE INGREDIENTS: WATER, PRESERVATIVE.
Warnings And Precautions
EXCESSIVE DOSES OF SODIUM FLUORIDE MAY RESULT IN FLUOROSIS OF TEETH IF TAKEN DURING FORMATION YEARS.
Package Label.Principal Display Panel
FLUORITAB FLUORIDE DROPSDISTRIBUTED BY:FLUORITAB CORPORATION"BETTER TEETH - BETTER HEALTH"MUSKEGON, MI 49441MADE IN U.S.A.
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