Label: TOTAL ADVANCED HEALTH FRESH MINT- cetylpyridinium chloride rinse

  • NDC Code(s): 35000-390-12, 35000-390-27, 35000-390-68
  • 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 December 5, 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 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

    Shake well to mix the two liquids before each use.

    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
  • 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, mineral oil, glycerin, sorbitol, flavor, benzyl alcohol, potassium sorbate, sodium benzoate, phosphoric acid, sodium saccharin, sucralose, simethicone, helianthus annuus (sunflower) seed oil, beta carotene, FD&C blue no. 1

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by: COLGATE-PALOLIVE COMPANY
    New York, NY 10022 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

    SHAKE
    TO ACTIVATE

    SEE THE RESULTS IN THE SINK

    Colgate®
    Antigingivitis Antiplaque Mouthwash

    Total®

    ADVANCED HEALTH
    HELPS IMPROVE THE HEALTH OF YOUR MOUTH

    ✓
    REDUCES PLAQUE
    ✓
    FRESHENS BREATH
    ✓
    HELPS PREVENT GINGIVITIS

    FRESH MINT
    ALCOHOL FREE†

    6.7 FL OZ
    (200 mL)

    P9917057

    PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TOTAL ADVANCED HEALTH FRESH MINT 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-390
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-390-68200 mL in 1 BOTTLE; Type 0: Not a Combination Product01/09/2017
    2NDC:35000-390-12400 mL in 1 BOTTLE; Type 0: Not a Combination Product01/09/2017
    3NDC:35000-390-27800 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35601/09/2017
    Labeler - Colgate-Palmolive Company (001344381)
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