Label: ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid

  • NDC Code(s): 41250-482-86
  • Packager: Meijer Distribution, Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 3, 2023

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  • Tamper Evident Statement

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Claims

    FOR BETTER ORAL HYGIENE AND FRESHER BREATH

  • Active ingredient

    Sodium fluoride 0.02% (0.01 w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the preveiontion of dental cavities

  • WARNINGS

    Warnings

  • 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.

  • 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
  • Inactive ingredients

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

  • Questions?

    1-888-593-0593

  • Warnings for CPC Containing Products

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

  • Disclaimer

    *Ths product is not manufactured or distributed by Procter & Gamble, distributor of Crest® Pro-Health® Advanced® Anticavity Fluoride Mouthwash.

    ** This product is not intended to replace brushing or flossing.

  • Adverse Reaction

    DISTRIBUTED BY

    MEIJER DISTRIBUTION, INC.

    2929 WALKER AVE NW

    GRAND RAPIDS, MI 49544

    www.meijer.com

    OUR QUALITY GUARANTEE

    WWW.MEIJER.COM/SATISFACTION

    The Meijer Family

  • Principal display panel

    NDC 41250-482-86

    meijer

    *COMPARE TO CREST® PRO-HEALTH® ANTICAVITY FLUORIDE MOUTHWASH ACTIVE INGREDIENT*
    ANTICAVITY

    Fluoride Rinse

    ALCOHOL FREE

    VIOLET MINT

    6 Benefits:

    Kills bad breath germs
    Helps prevent cavities
    Helps strengthen enamel
    Cleans teeth**
    Freshens breath
    No alcohol burn

    IMPORTANT: Read directions for proper use.

    1L (1.05 QT) 33.8 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ALCOHOL-FREE ANTICAVITY 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-482
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/22/2012
    Labeler - Meijer Distribution, Inc (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41250-482)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41250-482)
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