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

If you are a consumer or patient please visit this version.

View All Sections
  • 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

  • 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.
  • 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.
  • 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

  • INGREDIENTS AND APPEARANCE
    FLUORIDE DROPS  
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0288-5523
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0288-5523-0130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/09/2011
    Labeler - Fluoritab Corporation (005376702)
    Registrant - Fluoritab Corporation (005376702)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories002290302manufacture, analysis
    Establishment
    NameAddressID/FEIBusiness Operations
    Fluoritab Corporation005376702label
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!