Label: SENSODYNE EXTRA WHITENING COOL MINT- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0643-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 4, 2024

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  • Active ingredients

    Potassium nitrate 5%

    Sodium fluoride 0.24% (0.15% 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 25°C (77°F)
  • Inactive ingredients

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

  • 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.

    Exposed Dentin

    24/7

    Sensitivity Protection*

    + Strong & Healthy Teeth

    Use Sensodyne Extra Whitening

    Cool Mint twice dally:

    • Long lasting sensitivity protection* everyday

    • Contains fluoride to protect against cavities

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

    ©2022 GSK group of companies or its licensor.

    Distributed by: GSK Consumer Healthcare

    Warren, NJ 07059

  • Principal Display Panel

    SENSODYNE

    #1 DENTIST RECOMMENDED BRAND

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    24/7 Sensitivity Protection* + Strong & Healthy Teeth

    Extra Whitening

    Cool Mint

    NET WT 4.0 OZ (113 g)

    62000000079742 Front Carton

    Sensodyne Extra Whitening Cool Mint 4.0 OZ(113 g)
  • INGREDIENTS AND APPEARANCE
    SENSODYNE   EXTRA WHITENING COOL MINT
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0643
    Route of AdministrationDENTAL
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Cool) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0643-011 in 1 CARTON04/03/2023
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02204/03/2023
    Labeler - Haleon US Holdings LLC (079944263)
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