Label: COLGATE TRIPLE ACTION- sodium fluoride paste, dentifrice

  • NDC Code(s): 35000-941-46, 35000-941-47, 35000-941-48, 35000-941-58, view more
    35000-941-60, 35000-941-63, 35000-941-64, 35000-941-69, 35000-941-79, 35000-941-82, 35000-941-92, 35000-941-99
  • Packager: Colgate-Palmolive
  • Category: HUMAN OTC DRUG LABEL

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 December 10, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 yearsask a dentist or physician
  • 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

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE
    COMPANY
    New York 10022

  • 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
  • INGREDIENTS AND APPEARANCE
    COLGATE TRIPLE ACTION 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-941
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9) 220 mg  in 1 g
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE, WHITE, GREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-941-791 in 1 CARTON12/01/2010
    179 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-941-631 in 1 CARTON12/01/2010
    285 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-941-691 in 1 CARTON12/01/2010
    3113 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-941-461 in 1 CARTON12/01/2010
    4130 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-941-641 in 1 CARTON12/01/2010
    5181 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:35000-941-821 in 1 CARTON12/01/2010
    6232 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:35000-941-601 in 1 CARTON12/01/2010
    7170 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:35000-941-481 in 1 CARTON12/01/2010
    8226 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:35000-941-581 in 1 CARTON12/01/2010
    970 g in 1 TUBE; Type 0: Not a Combination Product
    10NDC:35000-941-921 in 1 CARTON12/01/2010
    10141 g in 1 TUBE; Type 0: Not a Combination Product
    11NDC:35000-941-991 in 1 CARTON11/09/2020
    1199 g in 1 TUBE; Type 0: Not a Combination Product
    12NDC:35000-941-471 in 1 CARTON12/14/2020
    12133 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35512/01/2010
    Labeler - Colgate-Palmolive (001344381)
    Registrant - Colgate-Palmolive Company (001344381)
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