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

  • NDC Code(s): 35000-263-02, 35000-263-30, 35000-263-33, 35000-263-60, view more
    35000-263-71
  • 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 June 6, 2022

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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, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Sodium Saccharin, Benzyl Alcohol, Mica, Blue 1, Titanium Dioxide.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton

    Colgate®
    Anticavity Fluoride Toothpaste

    OPTIC
    WHITE®

    STAIN FIGHTER®

    REMOVES 5X MORE SURFACE STAINS*
    WITH MICRO-POLISHING ACTION

    FRESH MINT GEL
    ENAMEL SAFE
    NET WT 2.0 OZ (56.6 g)

    Principal Display Panel - 56.6 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:35000-263
    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) 191.18 mg  in 1 g
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MICA (UNII: V8A1AW0880)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-263-711 in 1 CARTON06/01/2022
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-263-021 in 1 CARTON06/01/2022
    256.6 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-263-601 in 1 CARTON06/01/2022
    3170 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-263-331 in 1 CARTON06/01/2022
    436.8 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-263-301 in 1 CARTON06/01/2022
    585 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35506/01/2022
    Labeler - Colgate-Palmolive Company (001344381)
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