Label: SODIUM FLUORIDE solution/ drops

  • NDC Code(s): 58657-322-50
  • Packager: Method Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 10, 2023

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  • SPL UNCLASSIFIED SECTION

    SODIUM FLUORIDE- sodium fluoride solution/ drops

    Sodium Fluoride Drops 0.5 mg/mL

    GRAPE FLAVORED

  • Description

    Each mL of Sodium Fluoride Drops contains 0.5 mg Fluoride ion (F) from 1.1 mg Sodium Fluoride (NaF). For use as a dental caries preventive in pediatric patients. Sugar Free, Alcohol Free, Dye Free and Gluten Free.

    Supplement Facts

    Serving Size: 1 mL

    Servings Per Container: 50

          Amount per serving       % Daily Value

    Fluoride (as Sodium Fluoride)                   0.5 mg             **

    ** Daily Value not established.

    Active Ingredients: Sodium Fluoride (0.11% w/v).

    Other Ingredients: Glycerin, methylparaben, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

    FLUORIDE SUPPLEMENT DOSAGE SCHEDULES
    AGEFluoride Ion Level in Drinking Water (ppm)*
     < 0.3 ppm0.3 - 0.6 ppm > 0.6 ppm
    Birth to 6 monthsNoneNoneNone
    6 months to 3 yearsHalf dropperful 0.25 mg F (1/2 mL)NoneNone
    3 to 6 years One dropperful 0.5 mg F (1 mL)†Half dropperful 0.25 mg F (1/2 mL)None
    6 to 16 years Two dropperfuls 1 mg F (2 mL) One dropperful 0.5 mg F (1 mL)None

    * 1.0 ppm = 1 mg/Liter

    † 1.1 mg Sodium Fluoride contains 0.5 mg Fluoride ion

    Fluoride Supplement Dose Schedule approved by the American Dental Association, American Academy of Pediatrics and American Academy of Pediatric Dentistry.

    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 remineralization and by inhibiting the cariogenic microbial process.

  • Indications and Usage

    As a supplemental source of Fluoride. 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.1 Sodium Fluoride Drops were developed to provide systemic Fluoride for use as a supplement

    in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water Fluoride level does not exceed 0.6 ppm F.

  • Contraindications

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

  • Warnings

    Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. Keep out of the reach of infants and children.

  • 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 use in the eyes.

  • Adverse Reactions

    Allergic rash and other idiosyncrasies have been rarely reported.

    To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or Method Pharmaceuticals, LLC at 877-250-3427.

    Store at controlled room temperature 15° to 30°C (59° to 86°F).

  • Overdosage

    Prolonged daily ingestion of excessive Fluoride may result in varying degrees of dental fluorosis. The total amount of Sodium Fluoride in a bottle of 50 mL (0.5 mg/mL) Sodium Fluoride Drops (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes. If overdose is suspected, call 1-800-222-1222 (American Association of Poison Control Centers), your local poison control center (www.aapcc.org), or emergency room immediately for treatment recommendations.

  • Dosages and Administration

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

  • How Supplied

    50 mL bottles (58657-322-50)

  • References

    1. Accepted Dental Therapeutics, Ed. 40. American Dental

    Association, Chicago, 1984:399-402.

    2. Jakush, J, New Fluoride Schedule Adopted. ADA News.

    May 16, 1994:12-14.

    dropper

    Manufactured by:

    Method Pharmaceuticals, LLC

    Fort Worth, TX 76118

    Rev. 07/2018

  • PRINCIPAL DISPLAY PANEL

    NDC 58657-322-50

    Sodium

    Fluoride

    Drops

    Sodium Fluoride Oral Solution, USP

    0.5 mg/mL

    GRAPE FLAVORED

    1.69 FL. OZ. (50 mL)

    carton label

  • INGREDIENTS AND APPEARANCE
    SODIUM FLUORIDE 
    sodium fluoride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58657-322
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-322-5050 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/15/2018
    Labeler - Method Pharmaceuticals, LLC (060216698)