Label: SODIUM FLUORIDE DROPS- sodium fluoride solution/ drops

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated February 4, 2020

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

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size 1.0 mL
    Servings Per Container 50
    Amount Per Serving% Daily Value
    *
    Daily Value not established
    Fluoride0.5 mg*

    *U.S. Recommended Daily Allowance not established. Consult your physician for use by infants and children under 2 years of age.

    Active Ingredient: Sodium fluoride 0.11% (w/v).

    Other Ingredients: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sodium fluoride, sucralose, yellow #6.

    These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.

  • HEALTH CLAIM

    DOSAGE SCHEDULE* WATER F CONTENT
    AGE0-0.3 PPM0.3-0.6 PPM> 0.6 PPM
    *
    Conforms to new ADA and AAP guidelines for supplementation.
    6 months to 3 years0.25 mg F = 1/2 mL = Half dropperful00
    3-6 years0.5 mg F = 1 mL = One dropperful0.25 mg F = 1/2 mL = Half dropperful0
    6-16 years1 mg F = 2 mL = Two dropperfuls0.5 mg F = 1 mL = One dropperful0
  • Description

    Each 1 mL contains 0.5 mg fluoride ion (F-) from 1.1 mg of sodium fluoride (NaF). For use as a dental caries preventative in pediatric patients. Sugar-free and saccharin-free. Active Ingredient: Sodium fluoride 0.11% (w/v). Other Ingredients: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sodium fluoride, sucralose, yellow #6.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

  • CLINICAL PHARMACOLOGY

    Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting demineralization and by inhibiting the cariogenic microbial process.

  • USAGE

    It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries. Sodium Fluoride Drops 0.5 mg were developed to provided systemic fluoride for use as a supplement for patients living in areas where the drinking water fluoride level does not exceed 0.6 ppm F. See guidelines for supplementation from ADA and AAP.

  • CONTRAINDICATIONS

    Do not use in areas where drinking water exceed 0.6 ppm F. Do not administer to patients less than 6 months old.

  • WARNINGS

    See "CONTRAINDICATIONS" above.

  • PRECAUTIONS

    See "OVERDOSAGE" section. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Not for ophthalmic use.

  • ADVERSE REACTIONS

    Allergic rash or other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma at 1-866-592-6438 or the FDA at 1-800-FDA-1088 or www.fda.gov/med-watch.

  • OVERDOSAGE

    Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis. For safety purposes, the total amount of sodium fluoride in a 50 mL bottle of Sodium Fluoride Drops 0.5 mg (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispended at one time.

  • DOSAGE AND ADMINISTRATION

    Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F): 6 months to age 3: one-half dropperful (1/2 mL); age 3-6, one dropperful (1 mL); age 6-16, two dropperfuls (2 mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: 6 months to age 3, fluoride supplementation not indicated; age 3-6, one-half dropperful (1/2 mL); age 6-16, one dropperful (1 mL)1


    1
    Conforms to new ADA and AAP guidelines for supplementation.
  • HOW SUPPLIED

    Sodium Fluoride Drops 0.5 mg are available in 50 mL bottles with an accompanying calibrated dropper.

  • TAMPER EVIDENT

    Do not accept if printed bottle seal around cap is broken or missing.

  • *REFERENCES

    Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984, p.339-402. Jakush, J, New Fluoride schedule adopted. ADA New, May 16, 1994, p. 12, 14.

  • RECOMMENDED STORAGE

    Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. After opening, store away from direct light. Close tightly after each use. REFRIGERATION IS NOT REQUIRED.

  • HEALTH CLAIM

    Distributed by: H2-Pharma, LLC
    2010 Berry Chase Place, Montgomery, AL 36117
    www.h2-pharma.com

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

    61269-165-50

    Sodium Fluoride
    Drops

    Peach Flavored
    Sugar-free and Saccharin-free

    1⅔ fl. oz. (50 mL)

    0.5 mg

    H2 pharma

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    SODIUM FLUORIDE DROPS 
    sodium fluoride solution/ drops
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:61269-165
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEACH (UNII: 3OKE88I3QG)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:61269-165-501 in 1 CARTON
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT01/04/2017
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    Labeler - H2-Pharma, LLC (028473634)