Label: ANTIGINGIVITIS/ANTIPLAQUE- cetylpyridinium chloride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2023

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  • Claims

    Kroger®

    Powerful Fresh Mint

  • Active Ingredient

    Cetylpyridinium Chloride 0.05%

  • Purpose

    Antigingivitis, Antiplaque

  • Use

    helps control plaque that leads to gingivitis

  • Warnings

    for this product

  • Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
  • Keep out of reach of children under 6 years of age.

    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 & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
    • do not swallow
    • children 6 years to under 12 years of age: supervise use
    • when used after brushing, rinse mouth with water first
    • children under 6 years of age: do not use
  • Other information

    • this rinse is not intended to replace brushing or flossing
  • Inactive ingredients

    water, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6

  • Disclaimer

    This may cause temporary staining to the surface of teeth. 

    This is not harmful, and adequate brushing may prevent its occurrence.

    CREST® ABD PRO-HEALTH ARE TRADEMARKS OF PROCTER & gAMBLE, CINCINNATI, OH 45202. PROCTER & GAMBLE IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

  • Adverse Reaction

    DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

    FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900

    Our Brand, Our Guatantee. Love It or Your Money Back.

    www.kroger.com

  • Principal Panel Display

    meijer

    COMPARE TO the active ingredient in CREST® PRO-HEALTH® INTENSE CLEAN MINT MOUTHWASH

    *See Back Label

    Kroger®

    Powerful Fresh Mint

    Kills 99% of many bad breath germs^

    ANTIGINGIVITIS/ANTIPLAQUE

    HELPS KEEP TEETH CLEAN

    PARABEN FREE

    HELPS PREVENT PLAQUE & GINGIVITIS 

    FRESHENS BREATH

    SUGAR FREE

    COOLING

    ^Kills at least 99% of many organisms commonly assoicated with bed breath in as little as 15 seconds

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    133.8 FL OZ  (1.5 QT) 1 L

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIGINGIVITIS/ANTIPLAQUE 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-953
    Route of AdministrationOral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59450-953-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM505G(a)(3)11/13/2023
    Labeler - Kroger (006999528)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(59450-953)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(59450-953)
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