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

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

Drug Label Information

Updated July 24, 2018

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  • Active ingredients

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)

    Triclosan 0.30%

  • Purpose

    Anticavity

    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, flavor, cellulose gum, 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 U.S.A.
    www.colgatetotal.com

  • PRINCIPAL DISPLAY PANEL - 226 g Tube

    Helps Prevent Cavities • Gingivitis • Plaque

    Colgate ®
    Total ®
    Anticavity Fluoride and Antigingivitis Toothpaste

    ADVANCED WHITENING
    PASTE

    HELPS
    REMOVE &
    PREVENT
    STAINS*

    ADA
    ACCEPTED
    American
    Dental
    Association ®

    NET WT 8.0 OZ (226 g)

    Principal Display Panel - 226 g Tube
  • PRINCIPAL DISPLAY PANEL - 226 g carton

    Helps Prevent Cavities • Gingivitis • Plaque

    Colgate ®
    Total®
    Anticavity Fluoride and Antigingivitis Toothpaste

    ADVANCED WHITENING
    PASTE

    HELPS
    REMOVE &
    PREVENT
    STAINS*

    ADA
    ACCEPTED
    American
    Dental
    Association ®

    NET WT 8.0 OZ (226 g)

    Principal Display Panel - 226 g carton
  • INGREDIENTS AND APPEARANCE
    COLGATE  TOTAL ADVANCE WHITENING
    sodium fluoride and triclosan paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-350(NDC:35000-364)
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67659-350-06226 g in 1 TUBE; Type 1: Convenience Kit of Co-Package05/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02023108/09/2008
    Labeler - Team Technologies, Inc (192339703)
    Registrant - Team Technologies, Inc (192339703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Team Technologies, Inc079337800repack(67659-350) , relabel(67659-350)
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