Label: COLGATE TOTAL ADVANCED PRO-SHIELD PEPPERMINT BLAST- 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, FD&C blue no. 1

  • 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 - 1 L Bottle Label

    ALCOHOL FREE

    Colgate®

    Antigingivitis/Antiplaque Mouthwash

    Total®

    ADVANCED
    PRO-SHIELD     ™

    12-HR Protection Against Germs*

    • KILLS 99% OF GERMS ON CONTACT
    • SIGNIFICANTLY REDUCES PLAQUE
    • HELPS PREVENT GINGIVITIS
    • NO BURN OF ALCOHOL
    • FRESHENS BREATH

    PEPPERMINT BLAST™

    33.8 FL OZ
    (1.05 QT)
    1 L

    P9892866

    PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL ADVANCED PRO-SHIELD PEPPERMINT BLAST 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-500(NDC:35000-720)
    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)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67659-500-301000 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 finalpart35605/06/2013
    Labeler - Team Technologies, Inc (192339703)
    Registrant - Team Technologies, Inc (192339703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Team Technologies, Inc079337800relabel(67659-500) , repack(67659-500)
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