SENSODYNE RAPID RELIEF- stannous 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 ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, Antihypersensitivity

Uses

• aids in the prevention of dental cavities.
• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

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

• products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
• this product is specifically formulated to help prevent staining
• store below store below 30°C (86°F)

Inactive ingredients (Extra Fresh)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Inactive ingredients (Mint)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

Inactive Ingredients (Whitening)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC: 0135-0622-01

SENSODYNE® Rapid Relief

& Long Lasting Protection**

FAST RELIEF TOOTHPASTE*

*Significant pain relief in 3 days

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

WITH FLUORIDE

EXTRA FRESH

NET WT 3.4 OZ (96.4 g)

#1 Dentist Recommended Brand┼

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

┼#1 Dentist Recommended Brand for Sensitive Teeth

Fast RELIEF* and Long Lasting Protection**

Why use Sensodyne Rapid Relief?

Sensodyne Rapid Relief is clinically proven for fast relief of sensitivity pain. Its formula quickly creates a barrier over sensitive areas of your teeth to provide fast relief, and to help stop pain from coming back. With twice daily brushing, it builds ongoing protection from the pain of sensitive teeth. It will leave your mouth feeling clean and fresh, and also helps whiten and prevents staining.

**with twice daily brushing *significant pain relief in 3 days

EXPOSED DENTIN; CAUSE OF SENSITIVITY PAIN

TINY HOLES IN DENTIN

FAST ACTING FORMULA

QUICKLY CREATES A BARRIER

FAST RELIEF FROM PAIN*

ALWAYS FOLLOW THE LABEL

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

106027XB

Principal Display Panel

NDC: 0135-0621-01

SENSODYNE® Rapid Relief

& Long Lasting Protection**

FAST RELIEF TOOTHPASTE*

*Significant pain relief in 3 days

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

WITH FLUORIDE

MINT

NET WT 3.4 OZ (96.4 g)

#1 Dentist Recommended Brand┼

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

┼#1 Dentist Recommended Brand for Sensitive Teeth

Fast RELIEF* and Long Lasting Protection**

Why use Sensodyne Rapid Relief?

Sensodyne Rapid Relief is clinically proven for fast relief of sensitivity pain. Its formula quickly creates a barrier over sensitive areas of your teeth to provide fast relief, and to help stop pain from coming back. With twice daily brushing, it builds ongoing protection from the pain of sensitive teeth. It also helps whiten enamel and prevents staining.

**with twice daily brushing *significant pain relief in 3 days

EXPOSED DENTIN; CAUSE OF SENSITIVITY PAIN

TINY HOLES IN DENTIN

FAST ACTING FORMULA

QUICKLY CREATES A BARRIER

FAST RELIEF FROM PAIN*

ALWAYS FOLLOW THE LABEL

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

106026XB

Principal Display Panel

NDC: 0135-0632-01

SENSODYNERapid Relief

& Long Lasting Protection**

WHITENING

WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

NET WT 3.4 OZ (96.4 g)

*Significant pain relief in 3 days

#1 Dentist Recommended Brand for Sensitive Teeth

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

Why use Sensodyne Rapid Relief?

Sensodyne Rapid Relief is clinically proven for fast relief of sensitivity pain. Its formula quickly creates a barrier over sensitive areas of your teeth to provide fast relief, and to help stop pain from coming back. With twice daily brushing, it builds ongoing protection from the pain of sensitive teeth. It also helps whiten enamel and prevents staining.

*significant pain relief in 3 days **with twice daily brushing

EXPOSED DENTIN; CAUSE OF SENSITIVITY PAIN

TINY HOLES IN DENTIN

FAST ACTING FORMULA

QUICKLY CREATES A BARRIER

FAST RELIEF FROM PAIN*

Fast RELIEF* and Long Lasting Protection**

ALWAYS FOLLOW THE LABEL

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

©2019 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

62000000036861

INGREDIENTS AND APPEARANCE

SENSODYNE  RAPID RELIEF
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0622
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT (Extra Fresh)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0622-01	1 in 1 CARTON	01/08/2018
1		96.4 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	01/08/2018

SENSODYNE  RAPID RELIEF
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0621
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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: 0135-0621-01	1 in 1 CARTON	01/08/2018
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0621-02	1 in 1 CARTON	01/08/2018
2		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	01/08/2018

SENSODYNE  RAPID RELIEF
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0632
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

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: 0135-0632-01	1 in 1 CARTON	07/08/2019
1		96.4 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	07/08/2019

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

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