Label: COLGATE ZERO FRESH BREATH- cetylpyridinium chloride mouthwash

  • NDC Code(s): 35000-882-56
  • Packager: Colgate-Palmolive Company
  • 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 21, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Cetylpyridinium Chloride 0.075%

  • Purpose

    Antigingivitis/Antiplaque

  • Uses

    • helps prevent and reduce plaque and gingivitis
    • helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums
  • 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 increasing 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 12 years of age and oldervigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
    children 6 years to under 12 years of agesupervise use
    children under 6 years of agedo not use
  • Other information

    • this rinse is not intended to replace brushing or flossing
    • store at 59°F to 77°F
    • keep from freezing
  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Zinc Lactate, Flavor, Potassium Sorbate, Lactic Acid, Rebaudioside A.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE CO.
    New York, NY 10022 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 515 mL Bottle Label

    Colgate®

    zero

    KILLS 99% OF GERMS

    0% alcohol

    0% dyes

    0% artificial flavors

    Fresh Breath

    natural cool
    peppermint

    Antigingivitis/Antiplaque Mouthwash

    17.4 FL OZ (1.08 PT) 515 mL

    P9937239

    PRINCIPAL DISPLAY PANEL - 515 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE ZERO FRESH BREATH 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-882
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE15 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-882-56515 mL in 1 BOTTLE; Type 0: Not a Combination Product12/12/201912/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35612/12/201912/31/2022
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive785047999MANUFACTURE(35000-882)