Label: ANTICAVITY- sodium fluoride mouthwash

  • NDC Code(s): 55301-163-86
  • Packager: Your Military Exchanges
  • 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

  • Claims

    Multiple benefits

    Stengthens teeth to help prevent cavities

    Restores enamel

  • Active ingredient

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

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • WARNINGS

    Warnings

  • Keep out of reach of children.

    If more than ued 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
  • Other Information

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

    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

  • Disclaimer

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

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

  • Adverse Reaction

    "Satisfaction Guaranteed or Your Money Back."

    Manufactured For Your Military Exchanges

    By: Vi-Jon, LLC

    8515 Page Avenue, St. Louis, MO 63114

    DSP-TN-15000

    DSP-MO-34

    SDS-TN-15012

  • Principal display panel

    GREAT NEW FLAVOR

    exchange Select

    Compare to Listerine Total Care Fresh Mint Anticavity Mouthwash*

    Eucalyptus Mint

    ANTICAVITY MOUTHRINSE

    WITH FLUORIDE

    • Helps prevent cavities
    • Helps strengthen teeth
    • Helps restore enamel
    • Cleans the entire mouth**
    • Kills germs that cause bad breath
    • Freshens breath

    IMPORTANT: read directions for proper use.

    quality value

    1L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY  
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-163
    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)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    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:55301-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/29/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/29/2006
    Labeler - Your Military Exchanges (001695568)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55301-163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55301-163)
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