SENSODYNE COOLGEL- potassium nitrate and sodium fluoride gel 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 SENSODYNE ORIGINAL FLAVOR- potassium nitrate and sodium fluoride paste

Sensodyne by

Drug Labeling and Warnings

Sensodyne by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Potassium nitrate (5%)**

Sensodyne Cool Gel, 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)

Sensodyne Original: Sodium fluoride 0.23% (0.13% 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.

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 directed 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 (Cool Gel)

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

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

Inactive ingredients (Original)

water, sorbitol, glycerin, hydrated silica, cellulose gum, sodium methyl cocoyl taurate, silica, titanium dioxide, flavor, sodium saccharin, trisodium phosphate, red 28

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC: 0135-0527-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand†

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

Cool Gel

FRESH FLAVOR

24/7 SENSITIVITY PROTECTION*

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

Cool Gel

USE SENSODYNE®toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Freshens breath with a cool minty flavor

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

†#1 Dentist Recommended Brand for Sensitive Teeth

Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

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

This product contains no sugar.

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

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

ALWAYS FOLLOW THE LABEL

106032XA

Principal Display Panel

NDC: 0135-0525-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand†

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

Extra Whitening

24/7 SENSITIVITY PROTECTION*

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

Extra Whitening

USE SENSODYNE®toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Helps to remove stains for a whiter, brighter smile

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

†#1 Dentist Recommended Brand for Sensitive Teeth

†Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

This product contains no sugar.

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

©2012 GSK group of companies or its licensor. All rights reserved.

GSK Consumer Healthcare

Warren, NJ 07059

ALWAYS FOLLOW THE LABEL

105680XB

Principal Display Panel

NDC: 0135-0529-04

ADA Accepted

American Dental Association®

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand†

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

Fresh Mint

24/7 SENSITIVITY PROTECTION*

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

Fresh Mint

USE SENSODYNE®toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Freshens breath with a fresh minty flavor

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

†#1 Dentist Recommended Brand for Sensitive Teeth

†Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

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

This product contains no sugar.

©2012 GSK group of companies or its licensor. All rights reserved.

GSK Consumer Healthcare

Warren, NJ 07059

105702XB

ADA Accepted

American Dental Association®

• Helps prevent cavities
• Helps reduce tooth sensitivity

ALWAYS FOLLOW THE LABEL

Principal Display Panel

NDC: 0135-0528-04

SENSODYNE

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand†

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

Fresh Impact

Keeps Breath Feeling Fresh

24/7 SENSITIVITY PROTECTION*

SENSODYNE

MAXIMUM STRENGTH** WITH FLUORIDE

Fresh Impact

USE SENSODYNEtoothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Gives breath a long lasting freshening effect

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

†#1 Dentist Recommended Brand for Sensitive Teeth

Dentists have been recommending Sensodyne toothpaste for over 20 years. Brushing twice a day with Sensodyne toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

This product contains no sugar, like all ADA-accepted toothpastes.

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

©2016 GSK group of companies or its licensor.

GSK Consumer Healthcare, Warren, NJ 07059

ADA Accepted

American Dental Association®

• Helps prevent cavities
• Helps reduce tooth sensitivity

ALWAYS FOLLOW THE LABEL

105773XB

Principal Display Panel

NDC: 0135-0526-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand†

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

Original Flavor

24/7 SENSITIVITY PROTECTION*

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

Original Flavor

USE SENSODYNE®toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

†#1 Dentist Recommended Brand for Sensitive Teeth

†Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

This product contains no sugar.

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

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

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

ALWAYS FOLLOW THE LABEL

106031XA

INGREDIENTS AND APPEARANCE

SENSODYNE  COOLGEL
potassium nitrate and sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0527
Route of Administration	DENTAL

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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0527-04	1 in 1 CARTON	09/30/1990	11/30/2019
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	09/30/1990	11/30/2019

SENSODYNE  EXTRA WHITENING
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0525
Route of Administration	DENTAL

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	1.11 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0525-03	2 in 1 CARTON	09/30/1990
1		1 in 1 CARTON
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0525-04	1 in 1 CARTON	09/30/1990
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0135-0525-05	1 in 1 CARTON	09/30/1990
3		77 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 0135-0525-06	1 in 1 CARTON	09/30/1990
4		170 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 0135-0525-07	1 in 1 CARTON	09/30/1990
5		23 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 0135-0525-11	3 in 1 CARTON	09/30/1990
6		1 in 1 CARTON
6		184 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 0135-0525-13	4 in 1 CARTON	06/23/2016
7		184 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 0135-0525-08	1 in 1 CARTON	07/01/2019
8		184 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	09/30/1990

SENSODYNE  FRESH MINT
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0529
Route of Administration	DENTAL

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)
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
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0529-03	2 in 1 CARTON	12/16/2014
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0529-04	1 in 1 CARTON	09/30/1990
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0135-0529-05	1 in 1 CARTON	09/30/1990
3		77 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 0135-0529-01	1 in 1 CARTON	01/14/2019
4		23 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	09/30/1990

SENSODYNE  FRESH IMPACT
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0528
Route of Administration	DENTAL

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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	WHITE (white and blue)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0528-04	1 in 1 CARTON	07/01/2000
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	07/01/2000

SENSODYNE  ORIGINAL FLAVOR
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0526
Route of Administration	DENTAL

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	1.05 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM (UNII: 5HK03SA80J)
D&C RED NO. 28 (UNII: 767IP0Y5NH)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0526-04	1 in 1 CARTON	09/30/1990
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	09/30/1990

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)