Label: COLGATE TRIPLE ACTION- sodium fluoride paste, dentifrice 

  • Label RSS
  • NDC Code(s): 65954-536-46, 65954-536-60, 65954-536-63, 65954-536-64, view more
    65954-536-69, 65954-536-79, 65954-536-82
  • Packager: Mission Hills S.A de C.V
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

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

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  • Purpose

    Anticavity

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  • Use

    helps protect against cavities

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  • 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.

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  • 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
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  • Inactive ingredients

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

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  • Questions?

    1-800-468-6502

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  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE
    COMPANY
    New York 10022

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  • PRINCIPAL DISPLAY PANEL - 232 g Tube Carton

    Three Benefits for a Deep Clean

    Colgate®
    Fluoride Toothpaste

    NET WT 8.2 OZ (232 g)

    Triple
    Action

    Original Mint

    Cavity
    Protection
    1

    Whiter
    Teeth
    2

    Fresh
    Breath
    3

    PRINCIPAL DISPLAY PANEL - 232 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    COLGATE TRIPLE ACTION 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65954-536
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    HYDRATED SILICA 220 mg  in 1 g
    WATER  
    SORBITOL  
    POLYETHYLENE GLYCOL 600  
    FD&C BLUE NO. 1  
    SODIUM LAURYL SULFATE  
    COCAMIDOPROPYL BETAINE  
    SODIUM PYROPHOSPHATE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    FD&C YELLOW NO. 5  
    SACCHARIN SODIUM  
    XANTHAN GUM  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE, WHITE, GREEN Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65954-536-79 1 in 1 CARTON
    1 79 g in 1 TUBE
    2 NDC:65954-536-63 1 in 1 CARTON
    2 85 g in 1 TUBE
    3 NDC:65954-536-69 1 in 1 CARTON
    3 113 g in 1 TUBE
    4 NDC:65954-536-46 1 in 1 CARTON
    4 130 g in 1 TUBE
    5 NDC:65954-536-64 1 in 1 CARTON
    5 181 g in 1 TUBE
    6 NDC:65954-536-82 1 in 1 CARTON
    6 232 g in 1 TUBE
    7 NDC:65954-536-60 1 in 1 CARTON
    7 170 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 12/01/2010
    Labeler - Mission Hills S.A de C.V (812312122)
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