Label: COLGATE MAXFRESH WITH MINI BREATH CLEAN MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 35000-013-30, 35000-013-34, 35000-013-60, 35000-013-74, view more
    35000-013-78, 35000-013-95, 35000-013-97
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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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, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Sodium Saccharin, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide, Yellow 5.

  • 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

    10X
    LONGER
    LASTING
    COOL†

    Max Fresh®
    WITH WHITENING

    BREATH STRIPS

    Recyclable
    Tube

    NET WT 6.0 OZ (170 g)

    CLEAN MINT

    PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE MAXFRESH WITH MINI BREATH CLEAN MINT 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-013
    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)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-013-342 in 1 CARTON10/11/201312/31/2024
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-013-601 in 1 CARTON10/11/201312/30/2024
    2170 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-013-781 in 1 CARTON10/11/201312/31/2022
    3221 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-013-741 in 1 CARTON06/19/202010/31/2023
    4182 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-013-951 in 1 CARTON12/01/2021
    5178 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:35000-013-972 in 1 CARTON10/17/2022
    6178 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:35000-013-303 in 1 CELLO PACK07/24/2023
    71 in 1 CARTON
    7178 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02110/11/2013
    Labeler - Colgate-Palmolive Company (001344381)
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