Label: COLGATE TARTAR CONTROL WHITENING CRISP MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 35000-924-46, 35000-924-58, 35000-924-60, 35000-924-64, view more
    35000-924-69, 35000-924-79, 35000-924-82
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (0.16% 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, glycerin, PEG-12, pentasodium triphosphate, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, sodium saccharin, cellulose gum, carrageenan, titanium dioxide

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    Colgate®
    Anticavity
    Fluoride Toothpaste

    NET WT 4.0 OZ (113 g)

    Tartar
    Protection
    WHITENING

    Fights Tartar and
    Whitens Teeth

    CRISP MINT®
    paste

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE   TARTAR CONTROL WHITENING CRISP MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-924
    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) 405.57 mg  in 1 g
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM (UNII: 5HK03SA80J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-924-791 in 1 CARTON01/08/2011
    179 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-924-461 in 1 CARTON01/08/2011
    2130 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-924-641 in 1 CARTON01/08/2011
    3181 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-924-821 in 1 CARTON01/08/2011
    4232 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-924-601 in 1 CARTON01/08/2011
    5170 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:35000-924-691 in 1 CARTON01/08/2011
    6113 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:35000-924-581 in 1 CARTON01/08/2011
    770 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/08/2011
    Labeler - Colgate-Palmolive Company (001344381)
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