Label: COLGATE TOTAL ADVANCED CLEAN- sodium fluoride and triclosan gel, dentifrice

  • NDC Code(s): 65954-354-60
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 13, 2009

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

  • Active ingredient

    Sodium fluoride 0.24% (0.14% w/v fluoride ion)

    Triclosan 0.30%

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  • Purpose

    Anticavity

    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

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

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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
    Made in Mexico
    www.colgatetotal.com

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  • PRINCIPAL DISPLAY PANEL - 6.0 OZ Tube

    Helps Prevent Cavities • Gingivitis • Plaque

    Colgate®
    Anticavity Fluoride and Antigingivitis Toothpaste

    Total®
    Whitening
    Gel

    ADA
    ACCEPTED

    American
    Dental
    Association ®

    NET WT 6.0 OZ (170 g)

    Fights Tartar Buildup • Whitens Teeth

    Principle Display Panel - 6.0 OZ Tube
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  • PRINCIPAL DISPLAY PANEL - 6.0 OZ carton

    Helps Prevent Cavities • Gingivitis • Plaque

    Colgate®
    Anticavity Fluoride and Antigingivitis Toothpaste

    Total®
    Whitening
    Gel

    ADA
    ACCEPTED

    American
    Dental
    Association ®

    NET WT 6.0 OZ (170 g)

    Fights Tartar Buildup • Whitens Teeth

    Principle Display Panel - 6.0 OZ carton
    Close
  • INGREDIENTS AND APPEARANCE
    COLGATE  TOTAL ADVANCED CLEAN
    sodium fluoride and triclosan gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-354
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 2.4 mg  in 1 g
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 3 mg  in 1 g
    Product Characteristics
    Color WHITE, BLUE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65954-354-60 1 in 1 CARTON
    1 170 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020231 07/07/2009
    Labeler - Colgate-Palmolive Company (812312122)
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