Label: COLGATE TOTAL CLEAN IN BETWEEN- sodium fluoride and triclosan paste, dentifrice

  • NDC Code(s): 35000-384-16, 35000-384-66, 35000-384-69
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 13, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Sodium fluoride 0.24% (0.15% w/v fluoride ion)Anticavity
    Triclosan 0.30%Antigingivitis
  • Uses

    aids in the prevention of:

    • cavities
    • plaque
    • gingivitis
  • Warnings

    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 periodontitis, 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, flavor, sodium lauryl sulfate, cellulose gum, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY
    New York, NY 10022

  • PRINCIPAL DISPLAY PANEL - 164 g Tube Carton

    Colgate®
    Anticavity Fluoride and Antigingivitis Toothpaste

    Total®

    CLEAN-IN-BETWEEN

    CAVITIES
    PLAQUE
    GINGIVITIS
    ENAMEL
    TARTAR
    BREATH
    WHITENS

    Gel

    NEW
    MICRO-FOAMING
    FORMULA!

    NET WT 5.8 OZ (164 g)

    HELPS FIGHT PLAQUE BUILD-UP FOR HEALTHIER GUMS

    PRINCIPAL DISPLAY PANEL - 164 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL CLEAN IN BETWEEN 
    sodium fluoride and triclosan paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-384
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-384-161 in 1 CARTON10/18/2016
    121 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-384-691 in 1 CARTON10/18/2016
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-384-661 in 1 CARTON10/18/2016
    3164 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02023110/18/2016
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive785047999MANUFACTURE(35000-384)