Label: ALCOHOL FREE 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 28, 2022

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  • Active ingredient

    Cetylpyrdinium 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

  • Questions

    Call 1-800-632-6900

  • SPL UNCLASSIFIED SECTION

    Kroger

    FROM OUR FAMILY TO YOURS

    Mint

    ALCOHOL-FREE ANTISEPTIC RINSE

    ANTIGINGIVITIS/ANTIPLAQUE MOUTH RINSE

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

    *Crest Pro-Health Rinse is a registered trademark of The Procter & Gamble Company, Cincinnati, Ohio 45202. The Procter & Gamble Company is not affilitated with The Kroger Co. or this product.

    DISTRIBUTED BY

    THE KROGER CO

    CINCINNATI, OH 45202

    www.kroger.com

  • principal display panel

    Kroger

    ALCOHOL FREE ANTISEPTIC

    mouth rinse

    Antigingivitis/Antiplaque

    Kills germs

    Helps prevent plaque

    Helps keep teeth feeling clean

    Freshens breath

    No burn of alcohol

    mint

    33.8 FL OZ (1 L)

    image description

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE ANTISEPTIC 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-299
    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:30142-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/15/2009
    Labeler - Kroger Co (006999528)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(30142-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(30142-299)
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