Label: SENSODYNE ADVANCED WHITENING- potassium nitrate paste

  • NDC Code(s): 0135-0479-01, 0135-0479-02
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 4, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Potassium nitrate 5%

    Sodium fluoride 0.25% (0.16% w/v fluoride ion)

  • Purposes

    Antihypersensitivity, Anticavity

  • Uses

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
    • aids in the prevention of dental cavities.
  • Warnings

    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.
    • pain/sensitivity still persists after 4 weeks of use.

    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 older:
      • apply 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), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    • children under 12 years of age:Consult a dentist or doctor.
  • Other information

    • Do not store above 30° C (86 °F)
  • Inactive ingredients (Advanced Whitening)

    water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate PEG-8, alumina, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin, sucralose

  • Questions or comments?

    1-866-844-2797

  • Additional information

    ALWAYS FOLLOW THE LABEL

    What are sensitive teeth?

    Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or

    drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity,

    for example, with cold and hot food and drinks.

    What does Sensodyne do?

    Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness.

    *with twice daily brushing.

    24/7 Sensitivity Protection*

    + Strong & Healthy Teeth

    Use Sensodyne Advanced Whitening twice daily:

    • Long lasting sensitivity protection* every day

    • Contains fluoride to protect against cavities

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2020 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    62000000057087

  • Principal Display Panel

    NDC 0135-0479-01

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    Advanced Whitening

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    24/7 Sensitivity Protection* + Strong & Healthy Teeth

    NET WT 6.5 OZ (184 g)

    Sensodyne Advanced Whitening 6.5 oz (184 g)

  • INGREDIENTS AND APPEARANCE
    SENSODYNE   ADVANCED WHITENING
    potassium nitrate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0479
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0479-011 in 1 CARTON10/16/2020
    1184 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0479-024 in 1 CARTON07/03/2023
    2184 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/16/2020
    Labeler - Haleon US Holdings LLC (079944263)