Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

  • NDC Code(s): 11344-004-44
  • Packager: Consumer Product Partners, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 11, 2025

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  • Claims

    KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

  • Active ingredient

    Sodium fluoride 0.05% (0.02% 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., distributor of Act ® Bubblegum Blowout ®Anticavity Fluoride Rinse.

  • Adverse reaction

    Distributed by: Consumer Product Partners, LLC, 

    St. Louis, MO 63114, 1-888-593-0593

  • Principal display panel

    Sealed With Printed Neckband For Your Protection

    SWAN ®

    KIDS 

    ANTICAVITY 

    ALCOHOL FREE 

    FLUORIDE RINSE

    bubble gum 

    FLAVOR

    Strong Cavity Protection

    Compare to the active ingredient of Act ®Bubblegum Blowout ®Anticavity Fluoride Rinse*

    IMPORTANT:READ DIRECTIONS FOR PROPER USE

    ADA Accepted

    American Dental Association

    Helps prevent cavities

    18 FL OZ (1.12 PT) 532 mL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY FLUORIDE RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-004
    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 (UNII: 25IH6R4SGF)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISODIUM DIHYDROGEN HYPOPHOSPHATE (UNII: MR6TW8IQ9X)  
    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:11344-004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/29/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/29/2024
    Labeler - Consumer Product Partners, LLC (119091520)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(11344-004)
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