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

  • NDC Code(s): 35000-014-01, 35000-014-30, 35000-014-34, 35000-014-60, view more
    35000-014-70, 35000-014-73, 35000-014-74, 35000-014-78, 35000-014-79, 35000-014-95, 35000-014-97, 35000-014-99
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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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, methylcellulose, FD&C blue no. 1, titanium dioxide

  • 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†

    MaxFresh®
    WITH WHITENING

    BREATH STRIPS

    Recyclable
    Tube

    NET WT 6.0 OZ (170 g)

    COOL MINT

    PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE MAXFRESH WITH MINI BREATH COOL MINT 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-014
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-014-991 in 1 CARTON09/23/201312/31/2022
    153 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-014-601 in 1 CARTON09/23/201312/31/2024
    2170 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-014-342 in 1 CARTON09/23/201312/31/2024
    3170 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-014-781 in 1 CARTON09/23/201312/31/2023
    4215 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-014-011 in 1 CARTON09/23/201312/31/2022
    528 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:35000-014-791 in 1 CARTON09/23/201312/31/2022
    670 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:35000-014-701 in 1 CARTON11/30/201612/31/2022
    7215 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:35000-014-741 in 1 CARTON06/22/202006/30/2024
    8182 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:35000-014-951 in 1 CARTON12/01/2021
    9178 g in 1 TUBE; Type 0: Not a Combination Product
    10NDC:35000-014-731 in 1 CARTON01/10/2022
    10206 g in 1 TUBE; Type 0: Not a Combination Product
    11NDC:35000-014-972 in 1 CARTON10/17/2022
    11178 g in 1 TUBE; Type 0: Not a Combination Product
    12NDC:35000-014-303 in 1 CELLO PACK04/13/2023
    121 in 1 CARTON
    12178 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02109/23/2013
    Labeler - Colgate-Palmolive Company (001344381)
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