Label: COLGATE OPTIC WHITE STAIN FIGHTER SENS RELIEF- sodium fluoride paste, dentifrice

  • NDC Code(s): 35000-998-60, 35000-998-71
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 4, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Potassium Nitrate 5%Antisenstivity
    Sodium Fluoride 0.24% (0.15% w/v fluoride ion)Anticavity
  • Uses

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • helps protect against cavities
  • Warnings

    When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

    Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years of age and olderapply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
    children under 12 yearsconsult 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, 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

    Colgate®

    Anticavity Toothpaste for Sensitive Teeth

    OPTIC
    WHITE®

    STAIN FIGHTER®
    SENSITIVITY RELIEF

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

    ENAMEL SAFE

    NET WT 4.2 OZ (119 g)

    CLEAN MINT PASTE

    PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE STAIN FIGHTER SENS RELIEF 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-998
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 191.18 mg  in 1 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-998-711 in 1 CARTON11/01/2022
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-998-601 in 1 CARTON11/01/2022
    285 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02111/01/2022
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Hills, S.A. de C.V.812312122ANALYSIS(35000-998) , MANUFACTURE(35000-998) , PACK(35000-998) , LABEL(35000-998)
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