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

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)

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  • Purpose

    Anticavity

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  • Use

    helps protect against cavities

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  • 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.

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  • Directions

    adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 years ask a dentist or physician
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  • 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

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  • Questions or comments?

    Call toll-free 1-800-468-6502

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

    Bursting with Freshness That Lasts for Hours

    Colgate®
    Fluoride Toothpaste

    MaxFresh®
    WITH
    MINI BREATH STRIPS

    WHITENING

    COOL MINT

    NET WT 6.0 OZ (170 g)

    PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    COLGATE   MAX FRESH COOL MINT
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65954-014
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL 564.38 mg  in 1 g
    WATER  
    HYDRATED SILICA  
    POLYETHYLENE GLYCOL 600  
    SODIUM LAURYL SULFATE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    SODIUM PYROPHOSPHATE  
    COCAMIDOPROPYL BETAINE  
    SACCHARIN SODIUM  
    POWDERED CELLULOSE  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color BLUE Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65954-014-60 1 in 1 CARTON
    1 170 g in 1 TUBE
    2 NDC:65954-014-01 1 in 1 CARTON
    2 28.3 g in 1 TUBE
    3 NDC:65954-014-75 1 in 1 CARTON
    3 79 g in 1 TUBE
    4 NDC:65954-014-78 1 in 1 CARTON
    4 221 g in 1 TUBE
    5 NDC:65954-014-99 1 in 1 CARTON
    5 53 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 08/01/2011
    Labeler - Mission Hills S.A de C.V (812312122)
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