Label: ANTICAVITY- sodium fluoride rinse

  • NDC Code(s): 72476-971-86
  • Packager: RETAIL BUSINESS SERVICES, LLC
  • 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 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Sealed With Printed Neckband for Your Protection

  • 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 daily after brushing your teeth with a toothpaste
    • vigorously swish 10 mL 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 20°-25°C (68°–77°F)
    • cold weather may temporarily cloud this product
  • Inactive ingredients

    water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash

    DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

    SALISBURY, NC 28147

    For product questions and concerns,

    contact us at 1-833-992-3872

    Quality guaranteed or your money back.

  • Principal Panel Display

    CAREONE

    Compare to Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash*

    BURN FREE FLUORIDE

    ANTI-CAVITY MOTHWASH

    SODIUM FLUORIDE AND ACIDULATED

    PHOSPHATE TOPICAL SOLUTION

    HELPS STRENGTHEN TEETH TO FIGHT CAVITIES

    HELPS RESTORE ENAMEL

    FRESH MINT FLAVOR

    IMPORTANT: read directions for proper use.

    NET 33.8 FL OZ (1.05 QT) 1L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-971
    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)  
    sorbitol (UNII: 506T60A25R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    poloxamer 407 (UNII: TUF2IVW3M2)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    sodium benzoate (UNII: OJ245FE5EU)  
    phosphoric acid (UNII: E4GA8884NN)  
    eucalyptol (UNII: RV6J6604TK)  
    methyl salicylate (UNII: LAV5U5022Y)  
    thymol (UNII: 3J50XA376E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    menthol (UNII: L7T10EIP3A)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    sucralose (UNII: 96K6UQ3ZD4)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-971-861000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/08/2022
    Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72476-971)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(72476-971)
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