Label: COLGATE MAX FRESH COCONUT PINEAPPLE- sodium fluoride gel, dentifrice

  • NDC Code(s): 35000-789-86, 35000-789-99
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 8, 2026

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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, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Glycerin, Cocamidopropyl Betain, Sodium Saccharin, Hydroxypropyl Methylcellulose, Titanium Dioxide, Yellow 5.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 53.8 g Tube Carton

    Colgate®
    Anticavity Fluoride Toothpaste

    MaxFresh®

    FRESHNESS POWERED BY
    ULTRAFREEZE

    DELICIOUS FRUIT FLAVOR,
    MINTY COOL BREATH

    Fluoride Toothpaste

    Pineapple Coconut Crush
    FLAVOR

    WITH MINTY BREATH STRIPS

    NET WT 1.9 OZ (53.8 g)

    PRINCIPAL DISPLAY PANEL - 53.8 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE MAX FRESH COCONUT PINEAPPLE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-789
    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)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorPINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-789-861 in 1 CARTON11/24/2025
    1127 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-789-991 in 1 CARTON04/01/2026
    253.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02111/24/2025
    Labeler - Colgate-Palmolive Company (001344381)
    Registrant - Mission Hills, S.A. de C.V. (812312122)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Hills, S.A. de C.V.812312122ANALYSIS(35000-789) , MANUFACTURE(35000-789) , PACK(35000-789) , LABEL(35000-789)
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