Label: COLGATE TRIPLE ACTION ORIGINAL MINT FLUORIDE- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 18, 2010

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  • Active ingredient

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

  • Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

    Keep out of 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.

  • Directions

    • Adults and children 2 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 physician.
    • Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
    • Children under 2 years: Ask a dentist or physician.
  • Inactive ingredients

    sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

  • Questions or comments?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY
    New York, NY 10022
    Made in Canada
    www.colgate.com

  • PRINCIPAL DISPLAY PANEL - 130 g Tube

    Colgate®
    Fluoride Toothpaste

    NET WT 4.6 OZ (130 g)

    Triple
    Action

    Original Mint

    Cavity Protection
    1

    Whiter Teeth
    2

    Fresh Breath
    3

    Principal Display Panel - 130 g Tube
  • INGREDIENTS AND APPEARANCE
    COLGATE TRIPLE ACTION ORIGINAL MINT FLUORIDE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-536
    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
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Sodium Pyrophosphate (UNII: O352864B8Z)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorBLUE, WHITE (Stripe) , GREEN (Stripe) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51442-536-461 in 1 CARTON
    1130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/17/2010
    Labeler - Colgate-Palmolive Canada (259157246)
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