Label: SENSODYNE TRUE WHITE- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0579-01, 0135-0581-01, 0135-0581-02
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 7, 2024

If you are a consumer or patient please visit this version.

  • Active ingredients

    Potassium nitrate 5%**

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

  • Purpose

    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

    When using this product,

    if irritation occurs discontinue use.

    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:Consult a dentist or doctor.
  • Other information

    • store below 30°C (86°F)
  • Inactive ingredients

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

  • Questions or comments?

    Call toll-free 1-866-844-2797

  • Principal Display Panel

    NDC 0135-0581-01

    SENSODYNE ®

    TRUE

    white ®

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    MINT

    Sensitivity Relief*

    Stain Prevention • Stain Removal

    CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

    No. 1 DENTIST RECOMMENDED BRAND

    FOR SENSITIVE TEETH

    NET WT 3.0 OZ (85 g)

    Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne ®True White ®has the lowest abrasion formulation ever in a Sensodyne ®toothpaste.

    With twice daily brushing it:

    • is proven to relieve sensitivity pain
    • helps to gently whiten your teeth
    • leaves a protective shield to help prevent new stains forming
    • freshens breath, fights cavities and helps keep gums healthy

    *with twice daily brushing

    **maximum FDA sensitivity active ingredient

    GSKConsumer Healthcare

    Warren, NJ 07059

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

    ©2015 GSK group of companies or its licensor. All rights reserved

    ALWAYS FOLLOW THE LABEL

    105639XA

    105639XA_Sensodyne True White mint_3.0 oz.JPG
  • Principal Display Panel

    NDC 0135-0579-01

    SENSODYNE ®

    TRUE

    white ®

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    EXTRA FRESH

    Sensitivity Relief*

    Stain Prevention • Stain Removal

    CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

    No. 1 DENTIST RECOMMENDED BRAND

    FOR SENSITIVE TEETH

    NET WT 3.0 OZ (85 g)

    Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne ®True White ®has the lowest abrasion formulation ever in a Sensodyne ®toothpaste.

    With twice daily brushing it:

    • is proven to relieve sensitivity pain
    • helps to gently whiten your teeth
    • leaves a protective shield to help prevent new stains forming
    • freshens breath, fights cavities and helps keep gums healthy

    *with twice daily brushing

    **maximum FDA sensitivity active ingredient

    GSKConsumer Healthcare

    Warren, NJ 07059

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

    ©2015 GSK group of companies or its licensor. All rights reserved.

    ALWAYS FOLLOW THE LABEL

    105640XA 105640XA_Sensodyne True White Extra Fresh_3.0 oz.JPG

  • INGREDIENTS AND APPEARANCE
    SENSODYNE   TRUE WHITE
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0581
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0581-011 in 1 CARTON12/21/2015
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0581-021 in 1 CARTON12/21/2015
    223 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/21/2015
    SENSODYNE   TRUE WHITE
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0579
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (extra fresh) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0579-011 in 1 CARTON12/21/2015
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/21/2015
    Labeler - Haleon US Holdings LLC (079944263)