Label: ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid

  • NDC Code(s): 72476-482-86
  • 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 July 26, 2023

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  • TEP

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Active ingredients

    Sodium fluoride 0.02% (0.0 1% 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 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
  • Inactive ingredients

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

  • Claims

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

  • Dislcaimer

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Crest® Pro-Health™ Complete Anticavity Fluoride Rinse.

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

  • Adverse reaction

    DISTRIBUTED BY: FODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

    ©2018 S&S Brands, LLC

    Quality guaranteed or your money back.

  • Principal display panel

    CAREONE

    Compare to the Active Ingredient in Crest Pro-Health™ Advanced Anticavity Fluoride Mouthwash*

    ALCOHOL FREE

    FLUORIDE MOUTHWASH

    ANTICAVITY

    FLUORIDE RINSE

    VIOLET MINT FLAVOR

    KILLS BAD BREATH GERMS

    HELPS PREVENT CAVITIES

    HELPS STRENGTHEN ENAMEL

    CLEANS TEETH**

    FRESHENS BREATH

    IMPORTANT: Read directions for proper use

    33.8 FL OZ (1.05 QT) 1L

    image description

  • INGREDIENTS AND APPEARANCE
    ALCOHOL-FREE ANTICAVITY 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-482
    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)  
    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:72476-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/01/2013
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(72476-482)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(72476-482)
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