Label: MOUTH RINSE- sodium fluoride mouthwash

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

Drug Label Information

Updated October 13, 2023

If you are a consumer or patient please visit this version.

  • Claims

    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

    Warnings

  • 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 under 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 and then spit out

    •do not swallow the rinse

    •do not eat or drink anything for 30 minutes after rinsing

    •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 - 77⁰ F)

    •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, distributed of Listerine Total Care Fresh Mint Anticavity Mouthwash.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    TOPCO VIJA0219   QUESTIONS? 1-888-423-0139 topcare@topco.com

    This TOP CARE product is laboratory tested to guarantee its hightes quality. Your total satisfaction is guaranteed

    DSP-TN 15000  DSP-MO-34  SDS-TN-15012

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO LISTERINE TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH

    TopCare

    everyday

    FLUORIDE

    Anticavity

    Mouthwash

    SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

    EUCALYPTUS MINT

    6 Benefits

    • Helps prevent cavities
    • Strengthes teeth
    • Restores enamel
    • Kills bad breath germs
    • Freshens breath
    • Cleans entire mouth*

    *This product is not intended to replace brushing or flossing

    IMPORTANT: Read directions for proper use.

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

    image description

  • INGREDIENTS AND APPEARANCE
    MOUTH RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-001
    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)  
    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:36800-001-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/30/2010
    Labeler - Topco associates LLC (006935977)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(36800-001)