Label: ANTIGINGIVITIS/ANTIPLAQUE- cetylpyridinium chloride mouthwash

  • NDC Code(s): 11344-900-77
  • Packager: Consumer Product Partners, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 1, 2024

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

  • 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.

  • Tamper evident statement

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Adverse reaction

    Distributed by:

    Consuemr Product Partners, LLC

    St. Louis, MO 63114

    1-888-593-0593

  • Principal display panel

    SWAN ®

    COMPARE TO Crest ® Pro Health ®*

    $1.25

    GUM DEFENSE MOUTHWASH

    ANTIGINGIVITIS/ANTIPLAQUE

    SMOOTH MINT

    • Helps reduce early signs of gum disease
    • Kills the germs that cause bad breath
    • Alcohol free

    500 mL (1.05 PT) 16.9 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIGINGIVITIS/ANTIPLAQUE 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-900
    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:11344-900-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/01/2024
    Labeler - Consumer Product Partners, LLC (119091520)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(11344-900)