Label: COLGATE MAX FRESH COOL MINT- sodium fluoride gel, dentifrice

  • NDC Code(s): 65954-014-01, 65954-014-58, 65954-014-60, 65954-014-63, view more
    65954-014-75, 65954-014-78, 65954-014-95, 65954-014-99
  • Packager: Mission Hills S.A de C.V
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 9, 2019

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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

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

    Colgate®
    Anticavity
    Fluoride Toothpaste

    NET WT 6.0 OZ (170 g)

    COOL MINT

    Max Fresh®
    with WHITENING

    BREATH STRIPS

    FRESHNESS THAT LASTS FOR HOURS!

    PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE  MAX FRESH COOL MINT
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-014
    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) 564.38 mg  in 1 g
    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)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65954-014-601 in 1 CARTON08/01/201112/31/2022
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:65954-014-011 in 1 CARTON08/01/2011
    228.3 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:65954-014-751 in 1 CARTON08/01/201112/31/2018
    379 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:65954-014-781 in 1 CARTON08/01/201112/31/2016
    4221 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:65954-014-991 in 1 CARTON08/01/2011
    553 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:65954-014-581 in 1 CARTON08/01/2011
    670 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:65954-014-631 in 1 CARTON06/07/202212/31/2024
    7178 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:65954-014-951 in 1 CARTON05/28/2024
    8178 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02108/01/2011
    Labeler - Mission Hills S.A de C.V (812312122)
    Registrant - Colgate-Palmolive Company (001344381)
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