Label: ORAL ANTIVAVITY- sodium fluoride mouthwash

  • NDC Code(s): 41250-576-86
  • Packager: Meijer Distribution, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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

  • TEP

    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 prevention of dental cavities

  • Warnings

    For this product

  • 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 a day after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse bwtween 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 witout supervision
    • children under 6 years of age: consult a dentist or doctor
  • Inactive ingredients

    water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

  • Questions?

    1-888-593-0593

  • Disclaimer

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

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

    *This product is not manufactured or distributed by Procter and Gamble, distributor of Crest Pro-Health® Advanced® Anticavity Fluoride Mouthwash Multi-Protection Alcohol Free with Extra Deep Clean.

  • Adverse Reactions

    DISTRIBUTED BY

    MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    OUR QUALITY GUARANTEE

    WWW.MEIJER.COM/SATISFACTION

    The Meijer Family

  • Principal display panel

    NDC 41250-576-86

    meijer

    Compare to Crest Pro-Health® ANTICAVITY FLUORIDE MOUTHWASH ACTIVE INGREDIENT*

    ANTICAVITY 

    Fluoride Rinse

    ALCOHOL FREE

    REFRESHING MINT

    6 Benefits:

    Kills bad breath germs

    Helps prevent cavities

    Helps strengthen enamel

    Cleans teeth**

    Freshen breath

    No alcohol burn

    IMPORTANT: Read directions for proper use.

    1L (1.05 QT) 33.8 FL OZ 

    image description

  • INGREDIENTS AND APPEARANCE
    ORAL ANTIVAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-576
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-576-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/06/2015
    Labeler - Meijer Distribution, Inc (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41250-576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41250-576)