Label: ALCOHOL FREE- cetylpyridinium cloride 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 November 16, 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

    • 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 bwtween 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 of flossing
  • Inactive ingredients

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

  • Questions

    Call 1-888-593-0593

  • SPL UNCLASSIFIED SECTION

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    H-E-B

    Zesty Mint

    ALCOHOL FREE ANTIGINGIVITIS/ANTIPLAQUE

    This rinse may cause temporary staining to the surface of teeth.

    This is not harmful, and adequate brushing may prevent its occurance

    *This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint

    MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204

  • principal display panel

    Compare to Crest Pro-Health Rinse*

    H-E-B

    Zesty Mint

    ALCOHOL FREE ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE WITH CPC

    • Helps Prevent Plaque And Gingivitis
    • Helps Keep Teeth Feeling Clean
    • Helps Fight Germs That Cause Bad Breath

    33.8 FL OZ (1 QT) 1L

    image description

  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE 
    cetylpyridinium cloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-299
    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:37808-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/16/2009
    Labeler - H-E-B (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-299)