Label: ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid

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

Drug Label Information

Updated September 17, 2024

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

  • 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 (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 6 years of age: consult a dentist or doctor
  • Inactive ingredients

    water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

  • Questions?

    Call 1-800-423-0139

  • Disclaimer

    This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Crest® Pro-Health® Advanced Anticavity Fluoride Mouthwash, Enamel Care, Alcohol Free.

  • Adverse Reaction

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    Italsca, IL 60143

    ©TOPCO VIJA0724

    QUESTIONS? 1-888-423-0139

    topcare@topco.com www.topcarebrand.com

    QUALITY GUARANTEED

    Scan here for more information or call 1-888-423-0139

  • principal display panel

    Sealed with printed neckband for your protection

    Compare to Crest® Pro-Health® Advanced Anticavity Fluoride Mouthwash, Enamel Care, Alcohol Free*

    Topcare ®everyday

    Alcohol free Fluoride Anticavity Mouthwash

    Violet mint

    • Helps strengthen enamel
    • Helps prevent cavities
    • Helps keep mouth feeling clean
    • Kills bad breath germs
    • Freshens breath

    IMPORTANT: read directions for proper use.

    33.8 FL OZ (1.05 QT) 1 L

    image description

  • INGREDIENTS AND APPEARANCE
    ALCOHOL-FREE ANTICAVITY 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-482
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-482-861000 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 DrugM02109/19/2013
    Labeler - TOPCO Associates LLC (006935977)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(36800-482)