Label: FLUORIDE DROPS - sodium fluoride liquid

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated May 5, 2011

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  • 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)

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  • 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

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.
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  • WARNINGS

    CAUTION: FEDERAL (U.S.A.) LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.

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  • CONTRAINDICATIONS

    CONTRAINDICATIONS: PATIENTS WITH MEDICAL CONDITION OF DENTAL FLUOROSIS.
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  • PURPOSE

    PRODUCT CATEGORY: DENTAL CARIES PROPHYLACTIC, NUTRITIONAL SUPPLEMENT (MINERAL)

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  • 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.

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER, PRESERVATIVE.
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  • WARNINGS AND PRECAUTIONS

    EXCESSIVE DOSES OF SODIUM FLUORIDE MAY RESULT IN FLUOROSIS OF TEETH IF TAKEN DURING FORMATION YEARS. Close
  • PRINCIPAL DISPLAY PANEL

    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

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  • INGREDIENTS AND APPEARANCE
    FLUORIDE DROPS  
    sodium fluoride liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0288-5523
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    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 Business Operations
    Medical Products Laboratories 002290302 manufacture, analysis
    Establishment
    Name Address ID/FEI Business Operations
    Fluoritab Corporation 005376702 label
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