Label: COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH- cetylpyridinium chloride rinse

  • NDC Code(s): 35000-723-02, 35000-723-16, 35000-723-33, 35000-723-84
  • 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 1, 2019

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  • 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, flavor, potassium sorbate, citric acid, sodium saccharin, sucralose, FD&C green no. 3

  • 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™
    WHOLE MOUTH HEALTH

    GUM HEALTH
    HELPS FIGHT PLAQUE & GINGIVITIS

    45% Stronger, Healthier Gums*
    Fights Plaque Between Teeth & Along the Gum Line
    Helps Prevent Gingivitis

    10X LONGER LASTING COOL**

    CLEAN MINT

    16.9 FL OZ (1.05 PT) 500 mL

    P9930388

    Principal Display Panel - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-723
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-723-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
    2NDC:35000-723-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
    3NDC:35000-723-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
    4NDC:35000-723-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35603/01/2015
    Labeler - Colgate-Palmolive Company (001344381)
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