Label: ANTICAVITY- sodium fluoride rinse

  • 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 May 24, 2022

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  • Active Ingredients

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

  • Purpose

    Anticavity rinse

  • Use

    aids in the prevention of dental cavities

  • Warning

    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 immediately

  • 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 miute 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 room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰ 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

  • Disclaimer

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

    This TOPCARE product is laboratory tested to guarantee its highest quality.  Your total satisfaction is guaranteed.

  • Adverse reactions section

    DISTRIBUTED BY TOPCO ASOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    1-888-423-0139 TOPCO

    topcare@topco.com  www.topcarebrand.com

  • principal display panel

    COMPARE TO LISTERINE TOTAL CARE ZERO ANTICAVITY MOUTHWASH

    Top Care

    everyday

    ALCOHOL FREE - FLUORIDE

    Anticavity

    Mouthwash

    SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

    FRESH MINT

    6 Benefits

    • Alcohol free
    • Helps prevent cavities
    • Strengthens teeth
    • Restores enamel
    • Kills bad breath germs
    • Cleans entire mouth*

    *This product is not intended to replace brushing or flossing

    IMPORTANT:

    Read direction for proper use.

    33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-971
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 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)  
    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:36800-971-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/19/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/19/2013
    Labeler - TOPCO Associates LLC (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(36800-971)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(36800-971)
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