Label: ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid

  • NDC Code(s): 63940-482-86
  • Packager: Liberty Procurement, Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 31, 2024

If you are a healthcare professional or from the pharmaceutical industry 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, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

  • SPL UNCLASSIFIED SECTION

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

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

    ALCOHOL FREE

    COREVALUES

    Anticavity MOUTWASH FLUORIDE RINSE

    Distributed by

    Liberty Procurement, Inc

    650 Liberty Ave

    Union, NJ 07083 USA

  • principal display panel

    SEALED WITH

    PRINTED NECK BAND FOR YOUR PROTECTION

    ALCOHOL FREE

    COREVALUES

    *Compare to the active ingredient in Crest Pro-Health Complete

    Anticavity

    MOUTHWASH

    FLUOIRDE RINSE

    • Helps prevent cavities
    • Helps make enamel stronger
    • Helps clean the entire mouth
    • Helps freshen breath
    • Helps kill germs that cause bad breath

    Violet Mint

    IMPORTANT: Read directions for proper use.

    1L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ALCOHOL-FREE ANTICAVITY 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-482
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 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:63940-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/28/2016
    Labeler - Liberty Procurement, Inc (804085293)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(63940-482)