Label: COLGATE DEEP CLEAN FLUORIDE- sodium fluoride gel, dentifrice

  • NDC Code(s): 65954-777-58, 65954-777-60, 65954-777-79
  • Packager: Mission Hills S.A de C.V
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 17, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (0.14% 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

    water, sorbitol, hydrated silica, PEG-12, poloxamer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

    Colgate®
    Anticavity Fluoride Toothpaste

    PENETRATES BETWEEN TEETH FOR A RUSH OF CLEAN

    BRISK
    MINT    ®

    NET WT 6.0 OZ (170 g)

    NEW

    DEEP
    CLEAN
    WITH MICRO-FOAMING
    ACTION

    PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE DEEP CLEAN FLUORIDE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-777
    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
    WATER (UNII: 059QF0KO0R) 249.848 mg  in 1 g
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65954-777-601 in 1 CARTON01/29/2015
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:65954-777-791 in 1 CARTON01/29/201512/31/2018
    279 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:65954-777-581 in 1 CARTON01/29/2015
    370 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02101/29/2015
    Labeler - Mission Hills S.A de C.V (812312122)
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