Label: COLGATE MAXFRESH KNOCKOUT- sodium fluoride gel, dentifrice

  • NDC Code(s): 35000-214-30, 35000-214-95
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2025

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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

    Sorbitol, Water, Hydrated Silica, Flavor, Sodium Lauryl Sulfate, PEG-12, Sodium Saccharin, Cellulose Gum, Glycerin, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    DIST. BY:
    COLGATE-PALMOLIVE COMPANY,
    NEW YORK, NY 10022 USA

  • PRINCIPAL DISPLAY PANEL - 178 g Tube Carton

    Colgate®
    Anticavity
    Fluoride Toothpaste

    MaxFresh®
    FRESHNESS POWERED BY
    ULTRAFREEZE
    10X LONGER LASTING COOL FOR FRESH BREATH†

    KNOCKOUT®
    FIGHTS BAD BREATH
    & FOOD AFTERTASTES*

    Mint Fusion®
    WITH BREATH STRIPS

    NET WT 6.3 OZ (178g)

    Principal Display Panel - 178 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE MAXFRESH KNOCKOUT 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-214
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-214-951 in 1 CARTON02/03/2025
    1178 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-214-303 in 1 CELLO PACK02/03/2025
    21 in 1 CARTON
    2178 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02102/03/2025
    Labeler - Colgate-Palmolive Company (001344381)
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