Label: SENSODYNE ADVANCED WHITENING- potassium nitrate paste

  • NDC Code(s): 0135-0479-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 24, 2019

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  • 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

  • Principal Display Panel

    NDC 0135-0479-01

    SENSODYNE Advanced Whitening

    Maximum Strength** with Fluoride

    **maximum FDA sensitivity active ingredient

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    NET WT 6.5 OZ (184 g)

    9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

    #1 Dentist Recommended Brand for Sensitive Teeth

    Dentists have been recommending Sensodyne for many years. Sensodyne Advanced Whitening is a fluoride toothpaste. It can be used everyday and provides daily care for sensitive teeth.

    Sensodyne is specially formulated to relieve tooth sensitivity. When enamel is worn away or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity pain, for example, with hot and cold food and drinks.

    24/7 SENSITIVITY PROTECTION*

    24 hr protection*

    BEFORE: Sensitivity starts with exposed dentin. Sensitive teeth need special care.

    AFTER: Sensodyne Advanced Whitening works inside the tooth to help calm the nerves for 24 hr sensitivity protection.*

    *with twice daily brushing

    ADVANCED WHITENING

    Use Sensodyne Advanced Whitening twice daily:

    •
    Long lasting sensitivity protection
    •
    Helps bring back the natural whiteness of your teeth
    •
    Helps to remove stains for whiter teeth
    •
    Provides the benefits of a regular toothpaste

    This product contains no sugar.

    ALWAYS FOLLOW THE LABEL

    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

    62000000050449

    62000000050449_Sensodyne_Advanced_Whitening
  • 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/16/2020
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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