Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

  • NDC Code(s): 59779-004-44, 59779-004-77
  • Packager: CVS Pharmacy, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 9, 2024

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

  • Active ingredient

    Sodium fluoride 0.05% (0.02%w/v fluoride ion)

  • Purpose

    Anticavity 

  • Use

    aids in the prevention of dental cavities

  • Warning

    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 kids Fluorde Rinse.

  • Adverse reaction 

    Distributed by CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2024 CVS/pharmacy

    CVS.com®   1-800-shop-CVS

    V-16224

    100% money back guaranteed.

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  • principal display panel

    CVS

    Health

    Compare to ACT® Bubble Gum Blowout® Anticavity Kids Fluoride Rinse*

    Children's

    ANTICAVITY FLUORIDE RINSE

    • Helps prevent cavities
    • Helps Strengthen Teeth
    • Alcohol free

    Bubblegum Flavor

    ADA

    Accepted

    American

    Dental

    Association®

    Helps Prevent cavities

    IMPORTANT: Read directions for proper use

    Sealed with printed neckband for your protection

    18 FL OZ (1.12 PT) 532mL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY FLUORIDE RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-004
    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 ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-004-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/2004
    2NDC:59779-004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/08/2004
    Labeler - CVS Pharmacy, Inc (062312574)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(59779-004)