Label: COLGATE SIMPLY FRESH MINT- cetylpyridinium chloride mouthwash

  • 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 January 13, 2021

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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 using and ask dentist if

    • gingivitis, redness or bleeding persist for more than two 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 olderShake vigorously before use. Vigorously swish 20 mL (⅔ of 1 fl. oz. or 4 teaspoons) 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 ageunder adult supervision
    chldren under 6 years of agedo not use
  • Other information

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

    Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Flavor, Potassium Sorbate, Citric 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 - 475 mL Bottle Label

    swish

    SWISH AWAY
    99%
    OF GERMS

    SIMPLY
    FRESH MINT
    MOUTHWASH

    Colgate®

    Antigingivitis/Antiplaque Mouthwash

    16 FL OZ (1 PT) 475 mL

    Principal Display Panel - 475 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE SIMPLY FRESH MINT 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-892
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-892-52475 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/202112/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35601/13/202112/30/2023
    Labeler - Colgate-Palmolive (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company785047999ANALYSIS(35000-892) , LABEL(35000-892) , MANUFACTURE(35000-892) , PACK(35000-892)
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