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

  • 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 May 17, 2016

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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

  • Warnings

    Ask a dentist if condition persists or worsens after regular use.

    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 olderrinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day. Do not swallow.
    children 6 years to under 12 years of agesupervise use
    children under 6 years of agedo not use
  • Inactive ingredients

    water, glycerin, propylene glycol, sorbitol, poloxamer 407, flavor, potassium sorbate, citric acid, sodium saccharin, sucralose, FD&C green no. 3

  • Other Information

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

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY
    New York, NY 10022

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    ALCOHOL FREE

    Colgate®
    Antigingivitis Antiplaque Mouthwash

    Total®

    GUM HEALTH

    Advanced Gum Protection for
    45% Stronger, Healthier Gums*

    1. Fights plaque between teeth & along
      the gum line
    2. Kills 99% of germs on contact
    3. 12-hour protection against bacteria
      that cause gingivitis

    CLEAN MINT

    16.9 FL OZ
    (1.05 PT)
    500 mL

    P9903746

    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:67659-502(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:67659-502-301000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/01/2015
    Labeler - Team Technologies, Inc (192339703)
    Registrant - Team Technologies, Inc (192339703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Team Technologies, Inc079337800repack(67659-502) , relabel(67659-502)
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