Label: COLGATE- sodium fluoride and triclosan paste, dentifrice

  • NDC Code(s): 65954-003-78
  • Packager: Mission Hills, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated September 3, 2010

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Sodium fluoride 0.24% (0.14% 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, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, titanium dioxide

  • Questions or comments?

    Call toll-free 1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

    www.colgatetotal.com

  • PRINCIPAL DISPLAY PANEL - 221 g Tube Carton

    Helps Prevent Cavities • Gingivitis • Plaque

    Colgate®
    Anticavity Fluoride and Antigingivitis Toothpaste

    Total®

    Whitening Paste

    ADA
    Accepted
    American
    Dental
    Association ®

    NET WT 7.8 OZ (221 g)

    Fights Tartar Buildup • Whitens Teeth

    Principal Display Panel - 221 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE   TOTAL WHITENING
    sodium fluoride and triclosan paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-003
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.4 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)  
    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)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65954-003-781 in 1 CARTON
    1221 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02023110/01/2009
    Labeler - Mission Hills, S.A. de C.V. (812312122)