Label: ANTISEPTIC- cetylpyridinium chloride mouthwash

  • NDC Code(s): 63940-299-86
  • Packager: Liberty Procurement, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 31, 2024

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  • Active ingredient

    Cetylpyridinium chloride 0.07%

  • Purpose

    Antigingivitis, Antiplaque

  • Use

    helps control plaque that leads to gingivitis

  • Warnings

    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 20mL (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, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

  • Safety Information

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

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint.

    COREVLAUES

    Antiseptic

    MOUTHWASH

    ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

    MULTI-ACTION

    Distributed by

    Liberty Procurement, Inc.

    650 Liberty Ave.

    Union, NJ 07083 USA

    Visit us at www.facevalues.com

    299.005/299AK

  • principal display panel

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    ALCOHOL FREE

    COREVALUES

    Compare to Crest Pro-Health Clean Mint Antiseptic MOUTHWASH*

    ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

    MULTI-ACTION

    • Kills germs
    • Helps prevent plaque
    • Helps prevent gingivits
    • Freshens breath

    Zesty Mint

    1 L (33.8 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-299
    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)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/11/2016
    Labeler - Liberty Procurement, Inc (804085293)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(63940-299)
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