Label: SENSODYNE PRONAMEL GENTLE WHITENING- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL DAILY PROTECTION- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL FRESH BREATH- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL MULTI ACTION- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0460-01, 0135-0460-03, 0135-0460-06, 0135-0484-01, view more
    0135-0484-02, 0135-0484-03, 0135-0484-04, 0135-0484-05, 0135-0484-06, 0135-0520-01, 0135-0520-02, 0135-0520-05, 0135-0520-06, 0135-0568-04
  • 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 15, 2022

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

  • Active ingredients

    Potassium nitrate 5%

    Sodium fluoride 0.25% (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

    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 of age: Consult a dentist or doctor.
  • Other information (Gentle Whitening, Daily Protection, Fresh Breath, Multi-Action)

    store below 30°C (86°F)

  • Inactive ingredients (Gentle Whitening)

    water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

  • Inactive ingredients (Daily Protection)

    water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

  • Inactive ingredients (Fresh Breath)

    water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

  • Inactive ingredients (Multi-Action)

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

  • Questions or comments?

    Call toll-free 1-866-844-2797

  • Principal Display Panel

    NDC 0135-0484-01

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    GENTLE WHITENING

    STRENGTHENS AND RE-HARDENS ENAMEL

    PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

    NET WT 4.0 OZ (113g)

    WINE ACIDS

    FRUIT ACIDS

    SODA ACIDS

    9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

    #1 Dentist Recommended Brand for Strengthening & Protecting Enamel†

    MULTI-ACTION

    ACID PROTECTION FORMULA

    SENSODYNE PRONAMEL GENTLE WHITENING

    Brushing twice a day with ProNamel helps to:

    Protect enamel against the effects of acid erosion
    Restore natural whiteness
    Clean effectively and freshen breath
    Provide cavity protection
    Maintain healthy teeth and gums

    Pronamel is also suitable for people with sensitive teeth.

    Help protect your enamel against the effects acid erosion.

    Dentists have reported a growing dental health concern due to changing modern diets: acid erosion. Even teeth without cavities can be affected.

    *Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker, and sensitive. 

    SENSODYNE PRONAMEL Gentle Whitening toothpaste is formulated to protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. As it contains fluoride it also provides all the benefits of a regular toothpaste.

    #1 Dentist Recommended Brand For Strengthening and Protecting Enamel.

    †Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel has fluoride it helps protect against cavities too.

    ALWAYS FOLLOW THE LABEL

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

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2017 GSK

    106285XA

    1-866-844-2797

    Sensodyne Pronamel Gentle Whitening_4.0 OZ.JPG
  • Principal Display Panel

    NDC 0135-0460-01

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    DAILY PROTECTION

    STRENGTHENS AND RE-HARDENS ENAMEL

    PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

    MINTESSENCE

    ALPINE BREEZE

    NET WT 4.0 OZ (113g)

    WINE ACIDS

    FRUIT ACIDS

    SODA ACIDS

    9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

    #1 Dentist Recommended Brand for Strengthening and Protecting Enamel†

    SENSODYNE PRONAMEL DAILY PROTECTION

    USE WHENEVER YOU NORMALLY BRUSH

    Freshens breath
    Helps protect teeth against the effects of Acid Erosion
    Strengthens and re-hardens enamel
    Contains fluoride for cavity protection
    Suitable for sensitive teeth

    ProNamel is also suitable for people with sensitive teeth.

    Help protect your enamel against the effects of acid erosion.

    *Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive.

    SENSODYNE PRONAMEL DAILY PROTECTION toothpaste is formulated to help protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. As it contains fluoride it also provides all the benefits of a regular toothpaste.

    #1 Dentist Recommended Brand For Strengthening and Protecting Enamel.

    † Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel toothpaste has fluoride it helps protect against cavities too.

    ALWAYS FOLLOW THE LABEL

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

    GSK Consumer Healthcare

    Warren, NJ 07059

    1-866-844-2797

    106283XA

    This product contains no sugar.

    ©2017 GSK group of companies

    Sensodyne Pronamel Daily Protection_4.0 OZ.JPG
  • Principal Display Panel

    NDC 0135-0520-01

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    FRESH BREATH

    STRENGTHENS AND RE-HARDENS ENAMEL

    PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

    FRESH WAVE

    NET WT 4.0 OZ (113 g)

    WINE ACIDS

    FRUIT ACIDS

    SODA ACIDS

    9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

    #1 Dentist Recommended Brand for Strengthening and Protecting Enamel†

    MULTI-ACTION

    ACID PROTECTON FORMULA

    SENSODYNE PRONAMEL FRESH BREATH

    Brushing twice a day with ProNamel helps to:

    Protect enamel against the effects of acid erosion
    Freshen breath
    Strengthen and re-harden enamel
    Protect against cavities
    ProNamel is also suitable for people with sensitive teeth

    Help protect your enamel against the effects of acid erosion.

    *Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive.

    SENSODYNE PRONAMEL Fresh Breath toothpaste is formulated to help protect against the effects of acid erosion. It also contains fluoride providing the benefits of a regular toothpaste

    #1 Dentist Recommended Brand For Strengthening and Protecting Enamel.

    †Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel toothpaste has fluoride it helps protect against cavities too.

    ALWAYS FOLLOW THE LABEL

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2015 GSK

    1-866-844-2797

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

    106284XA

    5159

    Sensodyne Pronamel Fresh Breath_4.0 OZ.JPG
  • Principal Display Panel

    NDC 0135-0568-04

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    MULTI-ACTION

    STRENGTHENS AND RE-HARDENS ENAMEL

    PROTECTS AGAINST THE EFFECTS OF ACID EROSION*

    Cleansing Mint

    WINE ACIDS

    FRUIT ACIDS

    SODA ACIDS

    NET WT 4.0 OZ (113 g)

    9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

    #1 Dentist Recommended Brand for Strengthening and Protecting Enamel†

    MULTI-ACTION

    ACID PROTECTION FORMULA

    SENSODYNE PRONAMEL MULTI-ACTION

    Brushing twice a day with ProNamel helps to:

    Protect enamel against the effects of acid erosion
    Restore natural whiteness
    Clean effectively and freshen breath
    Provide cavity protection
    Maintain healthy teeth

    ProNamel is also suitable for people with sensitive teeth.

    Help protect your enamel against the effects of acid erosion.

    Dentists have reported a growing dental health concern due to changing modern diets: acid erosion’. Even teeth without cavities can be affected.

    *Acids in everyday food such as some fruit and acidic drinks, like orange juice and wine, can dissolve minerals from our teeth, softening the enamel surface which is then more easily worn away. As the enamel becomes thinner, teeth can become visibly less white, weaker and sensitive.

    SENSODYNE PRONAMEL Multi-Action toothpaste is formulated to help protect against the effects of acid erosion and also gently, yet effectively remove stains, helping restore teeth to their natural whiteness. As it contains fluoride it also provides the benefits of a regular toothpaste. Plus, its cleansing mint flavor helps keep your mouth feeling fresh and clean.

    #1 Dentist Recommended Brand For Strengthening and Protecting Enamel.

    †Dentists have been recommending Sensodyne for the past 20 years. ProNamel is from the makers of Sensodyne and is highly recommended by dentists. Brushing twice a day with ProNamel toothpaste strengthens enamel and protects against future acid attacks. And, since ProNamel toothpaste has fluoride it helps protect against cavities too.

    ALWAYS FOLLOW THE LABEL

    This product contains no sugar.

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

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2017 GSK group of companies or its licensor. All rights reserved.

    1-866-844-2797

    106286XA

    Sensodyne Pronamel Multi-Action_4.0 OZ.JPG
  • INGREDIENTS AND APPEARANCE
    SENSODYNE PRONAMEL  GENTLE WHITENING
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0484
    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) FLUORIDE ION1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (alpine breeze) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0484-011 in 1 CARTON10/18/2010
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0484-052 in 1 CARTON10/18/2010
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0484-021 in 1 CARTON10/18/2010
    376.5 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0135-0484-0322.6 g in 1 TUBE; Type 0: Not a Combination Product10/18/2010
    5NDC:0135-0484-041 in 1 CARTON07/01/2019
    5184.3 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:0135-0484-064 in 1 CARTON12/16/2014
    6184.3 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 finalpart35610/18/2010
    SENSODYNE PRONAMEL  DAILY PROTECTION
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0460
    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) FLUORIDE ION1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Mint Essence) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0460-011 in 1 CARTON10/18/2010
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0460-062 in 1 CARTON11/29/2017
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0460-031 in 1 CARTON10/18/2010
    3184.3 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 finalpart35610/18/2010
    SENSODYNE PRONAMEL  FRESH BREATH
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0520
    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) FLUORIDE ION1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (fresh wave) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0520-011 in 1 CARTON04/14/2011
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0520-0223 g in 1 TUBE; Type 0: Not a Combination Product04/14/2011
    3NDC:0135-0520-052 in 1 CARTON04/14/2011
    3113 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0135-0520-061 in 1 CARTON03/20/2015
    477 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 finalpart35604/14/2011
    SENSODYNE PRONAMEL  MULTI ACTION
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0568
    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) 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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Cleansing Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0568-041 in 1 CARTON12/09/2013
    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 finalpart35612/09/2013
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)