Label: SENSODYNE CLINICAL WHITE INTENSIVE CLEAN- potassium nitrate, sodium fluoride paste

  • NDC Code(s): 0135-5468-01, 0135-5468-03
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2024

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  • Active ingredients

    Potassium nitrate 5%

    Sodium fluoride 0.25% (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 thorough 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, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, alumina, titanium dioxide, xanthan gum, cocamidopropyl betain, sodium hydroxide, carrageenan, sodium saccharin

  • Questions or comments?

    1-866-844-2797

  • Generic Section

    ALWAYS FOLLOW THE LABEL

    SENSODYNE

    WHITE

    CLINICALLY PROVEN WHITENING DESIGNED FOR SENSITIVE TEETH

    WHITENING

    Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains

    SENSITIVITY PROTECTION

    Clinically proven ingredients to protect against sensitivity and strengthen enamel

    7X BETTER CLEANING^

    Through stain removal

    ENAMEL SAFE

    * As shown in an 8 week study.

    ** With twice daily brushing.

    ^ After 8 weeks twice daily brushing as compared to a non-whitening toothpaste.

  • Principal Display Panel

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    SENSODYNE

    2 SHADES WHITER TEETH*

    + 24/7 SENSITIVITY PROTECTION**

    CLINICAL WHITE

    #1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

    INTENSIVE CLEAN

    NET WT 3.4 OZ (96.4 g)

    Sensodyne Clinical White Intensive Clean 3.4 oz
  • INGREDIENTS AND APPEARANCE
    SENSODYNE  CLINICAL WHITE INTENSIVE CLEAN
    potassium nitrate, sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-5468
    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) SODIUM FLUORIDE1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    PEG-8 MONOSTEARATE (UNII: 2P9L47VI5E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-5468-011 in 1 CARTON12/31/2024
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-5468-033 in 1 CARTON12/31/2024
    296.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/31/2024
    Labeler - Haleon US Holdings LLC (079944263)
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