Label: ANTICAVITY- sodium fluoride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2023

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  • Tamper Evident Statement

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Active ingredient

    Sodium Fluoride 0.0221% (0.01% Fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • WARNINGS

    Warning
  • 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 12 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 12 years of age: consult a dentist or doctor

  • Other information

    • store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰F)
    • cold weather may temporarily cloud this product
  • INACTIVE INGREDIENT

    water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

  • Questions?

    Call 1-888-287-1915

  • Disclaimer

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

    *This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine® Total Care Anticavity Mouuthwash.

  • Adverse reaction

    Distributed by: Wal-Mart Stores, Inc.  Bentonville, AR 72716

    Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report and undesired reaction or side effect, please call 1-888-287-1915

    DSP-TN-15000

    DSP-MO-34

    SDS-TN-15012

  • Principal display panel

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    equate

    Compare to Listerine® Total Care Anticavity Mouthwash Active Ingredient*

    Anticavity

    Mouthwash

    Sodium fluoride and Acidulated Phosphate

    Phosphate Topical Solution

    Multiple Benefits in One

    • Helps prevent cavities
    • Restores enamel
    • Helps strengthen teeth
    • Helps kill bad breath germs
    • Freshens breath
    • Leaves the mouth feeling clean**

    Fresh Mint

    1 Liter (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-163
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MENTHOL (UNII: L7T10EIP3A)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    THYMOL (UNII: 3J50XA376E)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/13/2006
    Labeler - Wal-Mart (051957769)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon,LLC790752542manufacture(49035-163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon,LLC088520668manufacture(49035-163)
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