Label: COLGATE TOTAL ADVANCED WHITENING- sodium fluoride and triclosan paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 20, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

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

    aids in the prevention of:

    • cavities
    • plaque
    • gingivitis
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  • 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.

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  • Directions

    supervise children as necessary until capable of using without supervision.

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

    Antiplaque and antigingivitis use not proven in children.

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  • Inactive ingredients

    Hydrated silica, water, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, carrageenan, propylene glycol, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

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  • Questions or comments?

    Call toll-free 1-800-468-6502

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 164 g Tube Carton

    BETTER WHITENING*

    Colgate®
    Anticavity Fluoride and Antigingivitis Toothpaste

    Total®

    ADVANCED WHITENING

    NET WT 5.8 OZ (164 g)
    ADVANCED STAIN REMOVAL* FOR A BEAUTIFUL SMILE

    ✓ CAVITIES
    ✓ PLAQUE
    ✓ GINGIVITIS
    ✓ ENAMEL
    ✓ TARTAR
    ✓ BREATH
    ✓ WHITENS

    Gel

    Principal Display Panel - 164 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    COLGATE TOTAL ADVANCED WHITENING 
    sodium fluoride and triclosan paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67659-360(NDC:35000-354)
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.4 mg  in 1 g
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    Color green Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67659-360-07 164 g in 1 TUBE; Type 1: Convenience Kit of Co-Package 05/20/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020231 09/21/2010
    Labeler - Team Technologies, Inc (192339703)
    Registrant - Team Technologies, Inc (192339703)
    Establishment
    Name Address ID/FEI Business Operations
    Team Technologies, Inc 079337800 repack(67659-360) , relabel(67659-360)
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