Label: ANTISEPTIC- cetylpyridinium chloride mouthwash

  • NDC Code(s): 37012-299-86
  • Packager: Shopko Stores Operating
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 26, 2024

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

  • Active ingredients

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

  • SPL UNCLASSIFIED SECTION

    To OPEN:

    1. Remove Printed Tamper Evident Neckband

    2. Squeeze both tabs at Base of cap while turning the cap until loose.

    To CLOSE: Place cap back on bottle and turn cap until it clicks twice and feels secure.

    Sealed with printed neckband for your protection

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Rinse

    Manufactured by Vi-Jon, Inc.,

    One Swan Drive., Smyrna, TN37167

    For Shopko Stores Operating Co., LLC

    www.shopko.com

    For consumer questions call 1-888-593-0593

    Shopko Satisfaction Guaranteed By Refund Or Exchange

  • principal display panel

    SHOPKO

    Compare to the active ingredients of Crest

    Antiseptic Alcohol Free Oral Rinse Vivid Mint

    Antigingivitis/Antiplaque Mouthrinse

    Kills germs

    Helps prevent plaque

    Helps prevent gingivitis

    Helps keep teeth feeling clean

    Freshens breath

    No burn of alcohol

    33.8 FL OZ (1000 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-299
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/13/2009
    Labeler - Shopko Stores Operating (023252638)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(37012-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091520manufacture(37012-299)