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

  • NDC Code(s): 0135-0525-03, 0135-0525-04, 0135-0525-05, 0135-0525-06, view more
    0135-0525-07, 0135-0525-08, 0135-0525-11, 0135-0525-13, 0135-0525-14, 0135-0528-04, 0135-0529-01, 0135-0529-03, 0135-0529-04, 0135-0529-05, 0135-0529-10
  • 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 July 26, 2023

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  • Active ingredients

    Potassium nitrate (5%)

    Sensodyne Fresh Mint, and Fresh Impact: Sodium fluoride 0.25% (0.15% w/v fluoride ion)

    Sensodyne Extra Whitening: Sodium fluoride 0.24% (0.15% 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

    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.

  • Directions

    •
    adults and children 12 years of age and older:
    o
    apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    o
    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

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

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

  • Inactive ingredients (Fresh Mint)

    water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1

  • Inactive ingredients (Fresh Impact)

    water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, blue 1

  • Questions or comments?

    1-866-844-2797

  • Additional Information

    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

  • Principal Display Panel

    NDC 0135-0525-04

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    Extra Whitening

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth

    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.

    24/7 SENSITIVITY PROTECTION* +Strong & Healthy Teeth

    Use Sensodyne Extra Whitening twice daily:

    • Long lasting sensitivity protection• every day

    • Contains fluoride to protect against cavities

    NET WT 4.0 OZ (113g)

    53371 Front Carton

    Sensodyne Regular Extra Whitening 4 oz carton
  • Principal Display Panel

    NDC 0135-0529-04

    #1 Dentist Recommended Brand

    SENSODYNE

    Fresh Mint

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth

    NET WT 4.0 OZ (113g)

    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.

    24/7 SENSITIVITY PROTECTION* +Strong & Healthy Teeth

    Use Sensodyne Fresh Mint twice daily:

    • Long lasting sensitivity protection• every day

    • Contains fluoride to protect against cavities

    6209 Front Carton

    Sensodyne Fresh Mint 4 oz carton
  • Principal Display Panel

    NDC 0135-0528-04

    #1 Dentist Recommended Brand

    SENSODYNE

    Fresh Impact

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth

    NET WT 4.0 OZ (113g)

    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

    24/7 SENSITIVITY PROTECTION* +Strong & Healthy Teeth

    Use Sensodyne Fresh Impact twice daily:

    • Long lasting sensitivity protection• every day

    • Contains fluoride to protect against cavities

    6191 Front Carton

    Sensodyne Regular Fresh Impact 4 oz carton
  • INGREDIENTS AND APPEARANCE
    SENSODYNE  EXTRA WHITENING
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0525
    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 ION1.11 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM (UNII: 5HK03SA80J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    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:0135-0525-032 in 1 CARTON09/30/1990
    11 in 1 CARTON
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0525-041 in 1 CARTON09/30/1990
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0525-051 in 1 CARTON09/30/1990
    377 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0135-0525-061 in 1 CARTON09/30/1990
    4170 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:0135-0525-071 in 1 CARTON09/30/1990
    523 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:0135-0525-113 in 1 CARTON09/30/1990
    61 in 1 CARTON
    6184 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:0135-0525-134 in 1 CARTON06/23/2016
    7184 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:0135-0525-081 in 1 CARTON07/01/2019
    8184 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:0135-0525-144 in 1 CARTON07/01/2023
    9184 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 finalpart35609/30/1990
    SENSODYNE  FRESH MINT
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0529
    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)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0529-032 in 1 CARTON12/16/2014
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0529-041 in 1 CARTON09/30/1990
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0529-051 in 1 CARTON09/30/1990
    377 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0135-0529-011 in 1 CARTON01/14/2019
    423 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:0135-0529-1023 g in 1 TUBE; Type 0: Not a Combination Product01/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/30/1990
    SENSODYNE  FRESH IMPACT
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0528
    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)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorWHITE (white and blue) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0528-041 in 1 CARTON07/01/2000
    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 not finalpart35607/01/2000
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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