Label: ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 

  • Label RSS
  • NDC Code(s): 41250-482-86
  • Packager: Meijer Distribution, Inc
  • 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 10/12

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

  • Claims

    Sealed with printed neckband for your protection

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  • Claims

    Promotes fresh breath while fighting cavities

    Alcohol-free formula will not burn as it helps kill germs

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  • Active ingredients

    Active Ingredient

    Sodium fluoride 1.1219% (0.0 w/v fluoride ion)

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  • Purpose

    Purpose

    Anticavity

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  • Use

    Use aids in the preveiontion of dental cavities

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  • Warning

    Warning

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  • Keep out of reach of children

    Keep our 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

    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 and 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

    Inactive ingredients water, glycerin, flavor, cetylpyridinium chloride, phosphoric acid, methylparaben, sodium saccharin, poloxamer 407, propylparaben, propylene glycol, disodium phosphate, red 33, green3

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  • Claims

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

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  • Dislcaimer

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

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  • Adverse Reaction

    DISTRIBUTED BY

    MEIJER DISTRIBUTION, INC.

    2929 WALKER AVE NW

    GRAND RAPIDS, MI 49544

    www.meijer.com

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  • Principal Display panel

    Meijer

    Alcohol-Free

    ANTICAVITY

    FLUORIDE MOUTH RINSE

    • Helps prevent cavities
    • Helps strengthen enamel
    • Helps clean the entire mouth
    • Helps kiss germs that cause bad breath
    • No alcohol burn

    VIOLET MINT

    IMPORTANT: read directiosn for proper use

    1 L (33.8 FL OZ)

    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:41250-482
    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 DIHYDRATE  
    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:41250-482-86 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 02/22/2012
    Labeler - Meijer Distribution, Inc (006959555)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(41250-482)
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