Label: ANTICAVITY- sodium fluoride mouthwash

  • NDC Code(s): 49035-435-43, 49035-435-45
  • Packager: Wal-Mart Stores, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 14, 2022

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  • 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 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, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

  • Other information

    store at room temperature (59º-77ºF)

  • claims

    Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate and slightly or release air when opened.

  • Disclaimer

    This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Vibrant Anticavity Mouthrinse

    Satisfaction guaranteed- Or we'll replace it or give you your money back.  For questions or comments please call 1-888-287-1915

  • Adverse Reactions

    Distributed by: Wal-Mart Stores, Inc.,

    Bentonville, AR 72716

  • principal display panel

    equate

    Compare to Literine

    HeathyWhite

    Anticavity Mouthwash

    Glowing White

    Anticavity

    Mouthrinse

    • Begins working on contact
    • 5 days to whiter teeth
    • Helps strenghten teeth
    • Kills germs that cause bad breath

    FRESH MINT

    IMPORTANT: read directions for proper use.

    32 FL OZ (946 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-435
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
    2NDC:49035-435-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2015
    Labeler - Wal-Mart Stores, Inc (051957769)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(49035-435)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(49035-435)
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