Label: COLGATE TOTAL 12 HR PRO-SHIELD SPEARMINT SURGE- cetylpyridinium chloride rinse

  • NDC Code(s): 35000-731-02, 35000-731-16, 35000-731-33, 35000-731-50, view more
    35000-731-84
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 1, 2024

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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, sodium saccharin, citric acid, sucralose, FD&C green no. 3, FD&C yellow no. 6

  • 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

    12 HR PROTECTION*
    EVEN AFTER EATING AND DRINKING

    ANTIBACTERIAL

    Kills 99% of Germs on Contact
    Significantly Reduces Plaque
    Helps Prevent Gingivitis

    10X LONGER LASTING COOL**

    SPEARMINT

    P80040924

    16.9 FL OZ
    (1.05 PT) 500 mL

    PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL 12 HR PRO-SHIELD SPEARMINT SURGE 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-731
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-731-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/201512/31/2026
    2NDC:35000-731-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/201512/31/2026
    3NDC:35000-731-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/201512/31/2026
    4NDC:35000-731-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/201512/31/2026
    5NDC:35000-731-501500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/201512/31/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUG505G(a)(3)09/01/201512/31/2026
    Labeler - Colgate-Palmolive Company (001344381)
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