Label: COLGATE OPTIC WHITE CHARCOAL- sodium fluoride paste, dentifrice

  • NDC Code(s): 35000-988-71, 35000-988-78
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

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, Sodium Saccharin, Xanthan Gum, Charcoal Powder, Sodium Hydroxide, Blue 1, Red 40, Titanium Dioxide.

  • 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

    Colgate®
    Anticavity Fluoride Toothpaste

    OPTIC
    WHITE®
    WITH CHARCOAL

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

    COOL MINT PASTE
    ENAMEL SAFE
    NET WT 4.2 OZ (119 g)

    PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE CHARCOAL 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-988
    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
    WATER (UNII: 059QF0KO0R) 191.18 mg  in 1 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGRAY, WHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-988-711 in 1 CARTON05/05/2020
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-988-781 in 1 CARTON02/21/2022
    270.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02105/05/2020
    Labeler - Colgate-Palmolive Company (001344381)
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