Label: SODIUM FLUORIDE- sodium fluoride solution/ drops

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

Drug Label Information

Updated 05/11

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

  • SPL UNCLASSIFIED SECTION

    * Conforms to new ADA and AAP guidelines for supplementation.

    DOSAGE SCHEDULE * WATER F CONTENT
     AGE 0- 0.3 PPM 0.3-0.6 PPM > 0.6 PPM
    6 months to 3 years 0.25 mg F = 1/2 mL = Half dropperful 0 0
    3-6 years 0.5 mg F= 1 mL = One dropperful 0.25 mg F= 1/2 mL = Half dropperful 0
    6-16 years 1 mg F= 2 mL = Two dropperfuls 0.5 mg F= 1 mL = One dropperful 0
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  • DESCRIPTION

    Each mL of Sodium Fluoride Drops 0.5 mg 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 and saccharin-free.

    Active Ingredients: Sodium Fluoride 0.11% (w/v).
    Other Ingredients: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sucralose, yellow #6.

    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

    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 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
  • 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.

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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 www.fda.gov/medwatch.

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  • 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 dispensed at one time.

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  • 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)*

    * Conforms to new ADA and AAP guidelines for supplementation.

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  • HOW SUPPLIED

    Sodium Fluoride Drops 0.5 mg is supplied in 50 mL bottles with calibrated dropper,
    NDC 51862-165-50.

    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 News, May 16, 1994, p.12,14.

    RECOMMENDED STORAGE:

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

    Manufactured for:
    Libertas Pharma, Inc.
    Lawrenceville, GA 30043

    Iss. 03/11 165-50         743631

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  • Container Label

    NDC 51862-165-50

    Rx Only

    Sodium Fluoride Drops

    0.5 mg Drops

    Peach Flavored

    SUGAR and SACCHARIN FREE

    For Children and Adults

    1 2/3 fl. oz. (50 mL)

    Libertas
    Pharma Inc.

    Container Label

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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:51862-165
    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
    CITRIC ACID MONOHYDRATE  
    METHYLPARABEN  
    PEACH  
    WATER  
    D&C RED NO. 33  
    SODIUM BENZOATE  
    SUCRALOSE  
    FD&C YELLOW NO. 6  
    Product Characteristics
    Color ORANGE (peach) Score     
    Shape Size
    Flavor PEACH Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51862-165-50 1 in 1 CARTON
    1 50 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 05/21/2011
    Labeler - Libertas Pharma, Inc. (962128943)
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