Label: ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

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

  • Active ingredient

    Sodium fluoride 0.0219% (o.o1% w/v fluoride ion)

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  • Purpose

    Anticavity

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  • use

    aids in the prevention of dental cavities

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  • Warning Section

    Warnings

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  • Keep out of reach of children

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Adults and children 6 years of age and older:

    • use twice daily after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision
    • children under 6 years of age: consult a dentist or doctor
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  • Inactive ingredients

    water, glycerin, flavor, cetylpyridinium chloride, phosphoric acid, methylparaben, sodium saccharin, poloxamer 407, propylparaben, propylene glycol, disodium phosphate, red 33, green 3

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  • Questions

    Call 1-888-593-0593

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  • claim

    This rinse may cause temporary staining to the surface of teeth.  This is not harmful, and adequate brushing may prevent its occurrence.

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  • Disclaimer

    This product is not manufactured or distributed by Procter + Gamble,  distributor of Crest Pro-Health Complete Anticavity Fluride Rinse

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  • adverse reaction

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com

    Made in the U.S.A with U.S. and foreign components

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  • Principal Display Panel

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    Well at

    Walgreens

    ANTICAVITY FLUORIDE

    Mouth rinse

    • Helps prevent cavities + strengthen enamel
    • Alcohol free

    IMPORTANT: read directins for proper use

    MINT

    Compare to Crest Pro-Health Complete Anticavity Fluoride Rinse active ingredient

    33.8 FL OZ (1 L)

    image description

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  • INGREDIENTS AND APPEARANCE
    ALCOHOL-FREE ANTICAVITY 
    sodium fluoride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0482
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    GLYCERIN  
    CETYLPYRIDINIUM CHLORIDE  
    PHOSPHORIC ACID  
    METHYLPARABEN  
    SACCHARIN SODIUM  
    POLOXAMER 407  
    PROPYLPARABEN  
    PROPYLENE GLYCOL  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    D&C RED NO. 33  
    FD&C GREEN NO. 3  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0482-86 1000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 06/01/2013
    Labeler - Walgreen Co (008965063)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(0363-0482)
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