Label: ANTISEPTIC- cetylpyridinium chloride mouthwash

  • NDC Code(s): 37012-299-86
  • Packager: Shopko Stores Operating
  • 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 June 14, 2021

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)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    Does not containFD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0 mg  in 1 mL
    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 not finalpart35608/13/2009
    Labeler - Shopko Stores Operating (023252638)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37012-299)