Label: COLGATE TOTAL CLEAN MINT ANTIGINGIVITIS- sodium fluoride paste, dentifrice

  • NDC Code(s): 67751-131-01
  • Packager: Navajo Manufacturing Company Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 21, 2017

If you are a consumer or patient please visit this version.

  • Colgate Total Clean Mint ANTIGINGIVITIS TOOTHPASTE


  • Active ingredients

    Sodium Fluoride 0.24% (0.14% W/V Fluoride Ion)
    Triclosan 0.30%

  • Purpose

    Anticavity
    Antigingivitis

  • Uses

    Aids in the prevention of:

    • cavities
    • plaque
    • gingivitis
  • Warning


    Keep out of the reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Ask a dentist before use if you have

    • bleeding or redness lasting more than 2 weeks
    • pain, swelling, pus, loose teeth, or more spacing between teeth

    These may be signs of peridontitis , a serious form of gum disease.

  • Directions

    supervise children as necessary until capable of using without supervision.

    adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
    children under 12 yearsinstruct in good brushing and rinsing habits
    (to minimize swallowing)
    children under 6 yearsdo not use unless directed by a dentist or a physician

    Antiplaque and antigingivitis use not proven in children.

  • Inactive ingredients

    water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, carrageenan, propylene glycol, sodium saccharin, titanium dioxide.

  • Questions? Comments?

    Call toll-free 1-800-468-6502 or visit www.colgate.com

  • Principal Display Panel

    Principal Display Panel - Colgate Total

  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL CLEAN MINT ANTIGINGIVITIS 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-131
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.14 g  in 100 g
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-131-011 in 1 PACKAGE06/20/2017
    121.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02023106/24/2013
    Labeler - Navajo Manufacturing Company Inc (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Company068693167manufacture(67751-131)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc091917799relabel(67751-131) , repack(67751-131)