Label: ANTISEPTIC- cetylpyridinium chloride mouthwash

  • 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 23, 2021

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

    Warnings

  • 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

  • Questions

    Call 1-800-910-6874

  • SPL UNCLASSIFIED SECTION

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

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

    Use Up & Up alcohol free antiseptic mouth rinse for better oral hygiene and fresher breath.

    Dist. by Target Corp.

    Mpls., MN 55403

    Made in U.S.A. from U.S. and foreign components

    Shop Target.com

  • principal display panel

    SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    multi-action alcohol-free antiseptic mouth rinse

    CPC antigingivitis/antiplaque

    Compare to active ingredient in Crest Pro-Health Rinse*

    helps prevent and reduce plaque and gingivitis

    helps remove germs that cause bad breath

    up & up

    Fresh Mint Flavor

    50.7 FL OZ (1.5 L)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-299
    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:11673-299-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/21/2008
    Labeler - Target Corporation (006961700)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11673-299)