Label: ANTICAVITY RINSE- sodium fluoride mouthwash

  • NDC Code(s): 63941-904-77
  • Packager: Value Merchandisers, CO
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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

  • Active ingredient

    Sodium Fluoride 0.05% (0.2% 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, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Adults and children 6 years of age and older:

    • use once a day after brushing your teeth with a toothpaste
    • vigorously swish 10 milliliters 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

  • Other information

    store at room temperature

  • Inactive ingredients

    benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

  • Disclaimer

    This product is not manufactured or distributed by Chattem, Inc., distributer of Act ® Anticavity Kids Fluoride Rinse

  • Adverse reaction

    PROUDLY DISTRIBUTED BY:

    ASSOCIATED WHOLESALE GROCERS, INC.

    KANSAS CITY, KANSAS 66106

    Scan here for more product information.

    Call 1-844-292-1112 for mroe product information.

  • Principal display panel

    Best Choice ®

    Compare to the active ingredient in Act ® Anticavity Kids Fluoride Rinse*

    Children's ANTICAVITY FLUORIDE RINSE

    Bubble Gum Flavor

    ADA Accepted

    American Dental Association

    Helps prevent cavities

    Helps Prevent Cavities

    IMPORTANT: READ DIRECTIONS FOR PROPER USE

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    16.9 FL OZ (1.05 PT) 500mL

    mm01

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-904
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-904-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02107/29/2022
    Labeler - Value Merchandisers, CO (868703513)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(63941-904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091520manufacture(63941-904)