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

  • NDC Code(s): 35000-931-60, 35000-931-85
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 5, 2019

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  • Active ingredient

    Sodium fluoride 0.24% (0.14% 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 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.
  • 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

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    COLGATE MAX CLEAN   SPEARMINT BLAST
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-931
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE24 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R) 347 mg  in 1 g
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-931-851 in 1 CARTON08/01/2011
    1204 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-931-601 in 1 CARTON08/01/2011
    2170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35508/01/2011
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive785047999MANUFACTURE(35000-931)
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