Label: ANTIGINGIVITIS/ANTIPLAQUE- cetylpyridinium chloride mouthwash

  • NDC Code(s): 79481-0900-1
  • Packager: Meijer Distribution, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 30, 2024

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

  • Tamper Evident Statement

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Active Ingredient

    Cetylpyridinium Chloride 0.07%

  • 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, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, cinnamal, blue 1

  • Disclaimer

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

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Crest ®Pro-Health ®CPC Antiginigivitis/Antiplaque Oral Rinse Gum and Breath Purify Smooth Mint.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY 

    MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    OUR QUALITY GUARANTEE

    The Meijer Family

    WWW.MEIJER.COM/SATISFACTION

  • Principal Display Panel

    meijer

    COMPARE TO CREST® PRO-HEALTH ®GUM AND BREATH ACTIVE INGREDIENT*

    Gum Defense Mouthwash

    ANTIGINGIVITIS/ANTIPLAQUE

    ALCOHOL FREE

    SMOOTH MINT

    Kills germs that cause bad breath

    Helps defend against early signs of gum disease

    Helps improve gum hygiene

    1 L (1.5 QT) 33.8 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIGINGIVITIS/ANTIPLAQUE 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0900
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    CINNAMALDEHYDE (UNII: SR60A3XG0F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0900-11000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM505G(a)(3)11/08/2023
    Labeler - Meijer Distribution, INC (006959555)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(79481-0900)