Label: COLGATE 2IN1 WHITENING STAIN LIFTERS- sodium fluoride gel, dentifrice

  • NDC Code(s): 35000-907-81
  • 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 2, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (0.14% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of cavities

  • Warnings

    Keep out of the 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

    water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, sodium saccharin, cocamidopropyl betaine, cellulose gum, xanthan gum, titanium dioxide

  • Questions?

    Call toll-free 1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist.
    by:

    CP COLGATE-PALMOLIVE COMPANY
    New York, NY 10022

  • PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

    2 in 1

    Toothpaste
    & Mouthwash

    Colgate®
    Fluoride Toothpaste

    Cleans Teeth & Freshens Breath

    Whitening
    with Stain Lifters

    NET WT 4.6 OZ (130 g)
    LIQUID GEL

    Principal Display Panel - 130 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLGATE   2IN1 WHITENING STAIN LIFTERS
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-907
    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) 331.2 mg  in 1 g
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-907-81130 g in 1 BOTTLE; Type 0: Not a Combination Product07/26/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35507/26/2011
    Labeler - Colgate-Palmolive Company (001344381)
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