Label: SODIUM FLUORIDE- sodium fluoride solution/ drops 

  • NDC Code(s): 44946-1032-8
  • Packager: Sancilio & Company Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 12/12

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

  • SPL UNCLASSIFIED SECTION

    GRAPE FLAVORED

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  • 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. No dyes, artificial flavors or sugar. Saccharin free. Gluten free.

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

    Other Ingredients: Glycerin, purified water, xylitol, propylene glycol, natural grape flavor, sucralose, methyl paraben, propyl paraben.

    FLUORIDE SUPPLEMENT DOSAGE SCHEDULE§
    AGE Fluoride Ion Level in Drinking Water (ppm)*
    < 0.3 ppm 0.3 - 0.6 ppm > 0.6 ppm
    *
    1.0 ppm = 1 mg/Liter
    1.1 mg Sodium Fluoride contains 0.5 mg Fluoride ion
    Birth to 6 months None None None
    6 months to 3 years Half dropperful
    0.25 mg F (1/2 mL)
    None None
    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

    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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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 Sancilio & Company, Inc. at 1-800-SCI-0513.

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  • STORAGE AND HANDLING

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

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  • TAMPER EVIDENT

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

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Dosage§ 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).

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  • How Supplied

    50 mL bottles (44946-1032-8)

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  • 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.
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  • SPL UNCLASSIFIED SECTION

    Figure

    Lot No:

    Exp Date:

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  • SPL UNCLASSIFIED SECTION

    Manufactured by: Sancilio & Company, Inc.
    3874 Fiscal Court #200
    Riviera Beach, FL 33404

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  • PRINCIPAL DISPLAY PANEL - 0.5 mg Bottle Carton

    44946-1032-8
    Rx Only

    SCI
    Sancilio & Company, Inc.
    Developing Good Science into Great Medicine

    Sodium
    Fluoride
    Drops

    0.5
    mg/mL

    GRAPE FLAVORED

    NO DYES, ARTIFICIAL FLAVORS OR SUGAR
    SACCHARIN FREE
    GLUTEN FREE

    1⅔ FL. OZ. (50 mL)
    Made in the U.S.A.

    Principal Display Panel - 0.5 mg Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    SODIUM FLUORIDE 
    sodium fluoride solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44946-1032
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin  
    Water  
    Xylitol  
    Propylene glycol  
    Sucralose  
    Methylparaben  
    Propylparaben  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44946-1032-8 50 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 12/20/2011
    Labeler - Sancilio & Company Inc (176681257)
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