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
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NDC Code(s):
0135-0460-01,
0135-0460-03,
0135-0460-06,
0135-0484-01, view more0135-0484-02, 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
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 healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
-
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)
- Inactive ingredients (Gentle Whitening)
- Inactive ingredients (Daily Protection)
- Inactive ingredients (Fresh Breath)
- Inactive ingredients (Multi-Action)
- Questions or comments?
-
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
-
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
-
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
-
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
-
INGREDIENTS AND APPEARANCE
SENSODYNE PRONAMEL GENTLE WHITENING
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0484 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor MINT (alpine breeze) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0484-01 1 in 1 CARTON 10/18/2010 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0484-05 2 in 1 CARTON 10/18/2010 2 113 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0135-0484-02 1 in 1 CARTON 10/18/2010 3 76.5 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:0135-0484-03 22.6 g in 1 TUBE; Type 0: Not a Combination Product 10/18/2010 5 NDC:0135-0484-04 1 in 1 CARTON 07/01/2019 5 184.3 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:0135-0484-06 4 in 1 CARTON 12/16/2014 6 184.3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/18/2010 SENSODYNE PRONAMEL DAILY PROTECTION
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0460 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor MINT (Mint Essence) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0460-01 1 in 1 CARTON 10/18/2010 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0460-06 2 in 1 CARTON 11/29/2017 2 113 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0135-0460-03 1 in 1 CARTON 10/18/2010 3 184.3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/18/2010 SENSODYNE PRONAMEL FRESH BREATH
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0520 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor MINT (fresh wave) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0520-01 1 in 1 CARTON 04/14/2011 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0520-02 23 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2011 3 NDC:0135-0520-05 2 in 1 CARTON 04/14/2011 3 113 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:0135-0520-06 1 in 1 CARTON 03/20/2015 4 77 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 04/14/2011 SENSODYNE PRONAMEL MULTI ACTION
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0568 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor MINT (Cleansing Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0568-04 1 in 1 CARTON 12/09/2013 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/09/2013 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)