Label: COLGATE TOTAL ACTIVE PREVENTION PEPPERMINT- cetylpyridinium chloride rinse

  • NDC Code(s): 35000-279-16, 35000-279-31, 35000-279-80, 35000-279-84
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 3, 2024

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

View All Sections
  • 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
  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Zinc Lactate, Flavor, Potassium Sorbate, Lactic Acid, Sodium Saccharin, Sucralose, Blue 1.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    ALCOHOL FREE

    Colgate®
    Antigingivitis Antiplaque Mouthwash

    Total
    ACTIVE PREVENTION

    PEPPERMINT

    24 HOUR ANTIBACTERIAL PROTECTION1

    Fight Root Cause2 of:

    ✓Gingivitis ✓Plaque ✓Tartar Buildup

    ADA
    Accepted
    American
    Dental
    Association ®

    CLINICALLY
    PROVEN

    16.9 FL OZ (1.05 PT) 500 mL

    PS0073264

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL ACTIVE PREVENTION PEPPERMINT 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-279
    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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-279-8060 mL in 1 BOTTLE; Type 0: Not a Combination Product10/31/2024
    2NDC:35000-279-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product10/31/2024
    3NDC:35000-279-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/31/2024
    4NDC:35000-279-311000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUG505G(a)(3)10/31/2024
    Labeler - Colgate-Palmolive Company (001344381)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!