Label: COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 35000-936-02, 35000-936-33, 35000-936-60, 35000-936-71
  • 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 9, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (0.15% 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

    water, hydrated silica, sorbitol, glycerin, PEG-12, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, cocamidopropyl betaine, benzyl alcohol, sodium saccharin, xanthan gum, sodium hydroxide, mica, titanium dioxide, FD&C blue no. 1

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

    NEW
    STAIN REMOVAL
    TECHNOLOGY**

    Colgate®

    OPTIC
    WHITE®

    STAIN FIGHTER ™

    REMOVES 6X MORE SURFACE STAINS*
    WITH MICRO-POLISHING ACTION

    NET WT 4.2 OZ (119 g)
    ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE WHITENING

    FRESH MINT GEL

    PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-936
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 191.17 mg  in 1 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-936-711 in 1 CARTON11/30/2017
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-936-601 in 1 CARTON12/19/2018
    2170 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-936-021 in 1 CARTON03/12/2019
    356.6 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-936-331 in 1 CARTON03/18/2020
    436.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/30/2017
    Labeler - Colgate-Palmolive Company (001344381)
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