Label: ANTISEPTIC- cetylpyridinium chloride mouthwash

  • NDC Code(s): 63940-299-86
  • Packager: Liberty Procurement, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 25, 2023

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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 not finalpart35607/11/2016
    Labeler - Liberty Procurement, Inc (804085293)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63940-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(63940-299)
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