Label: COLGATE MAX CLEAN SPEARMINT BLAST- sodium fluoride gel, dentifrice

  • NDC Code(s): 65954-382-60, 65954-382-85
  • 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.

  • Active ingredient

    Sodium fluoride 0.24% (0.14% 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

    water, sorbitol, hydrated silica, PEG-12, poloxamer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, methylcellulose, mica, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

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  • Questions?

    1-800-468-6502
    www.colgate.com/maxclean

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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 Label

    Colgate®
    Anticavity Fluoride Toothpaste

    WITH WHITENING
    MaxClean™
    SMARTFOAM®

    30% More Foam*
    Cleans Tough to Reach Spaces

    SPEARMINT BLAST®

    NET WT 6.0 OZ (170 g)

    Principal Display Panel - 170 g Tube Label
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  • INGREDIENTS AND APPEARANCE
    COLGATE MAX CLEAN   SPEARMINT BLAST
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65954-382
    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 347 mg  in 1 g
    WATER  
    HYDRATED SILICA  
    POLYETHYLENE GLYCOL 600  
    POLOXAMER 407  
    SODIUM LAURYL SULFATE  
    XANTHAN GUM  
    COCAMIDOPROPYL BETAINE  
    SODIUM PYROPHOSPHATE  
    MICA  
    TITANIUM DIOXIDE  
    FERRIC OXIDE RED  
    POWDERED CELLULOSE  
    SACCHARIN SODIUM  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 5  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor SPEARMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65954-382-85 1 in 1 CARTON
    1 204 g in 1 TUBE
    2 NDC:65954-382-60 1 in 1 CARTON
    2 170 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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