Label: FLUORIDE DROPS - sodium fluoride liquid

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

Drug Label Information

Updated 05/11

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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 LABEL 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 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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