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

  • NDC Code(s): 0135-0579-01, 0135-0581-01, 0135-0581-02
  • 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 December 14, 2020

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

    GSK Consumer 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

    GSK Consumer 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

    105640XA105640XA_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 not finalpart35612/21/2015
    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 not finalpart35612/21/2015
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)