SENSODYNE SENSITIVITY AND GUM MINT- stannous fluoride paste SENSODYNE SENSITIVITY AND GUM WHITENING- 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, Antigingivitis, Antihypersensitivity

Uses

• aids in the prevention of dental cavities.
• helps control bleeding gums.
• Helps interfere with harmful effects of plaque associated with gingivitis.
• 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.
• gingivitis, bleeding, or redness persists for more than 2 weeks.
• you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These maybe signs or symptoms of periodontitis, a serious form of gum disease.

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 25°C (77°F)

Inactive ingredients (Sensitivity & Gum Whitening)

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

Inactive ingredients (Sensitivity & Gum Mint)

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

Questions or comments?

1-866-844-2797

Principal Display Panel

NDC: 0135-5024-01

new

SENSODYNE

WITH FLUORIDE

SENSITIVITY & GUM

IMPROVES GUM HEALTH

WHITENING

LOW ABRASION FORMULA

DUAL ACTION TOOTHPASTE

TOOTHPASTE FOR SENSITIVE TEETH, GINGIVITIS AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4g)

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Sensitivity & Gum?

Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity & improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.

SENSITIVE AREAS AND SWOLLEN BLEEDING GUMS

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS

TARGETS & HELPS REMOVE PLAQUE BACTERIA

RELIEVES TOOTH SENSITIVITY* & IMPROVES GUM HEALTH

*with twice daily brushing

Dual Action forTOOTH SENSITIVITY & GUM PROBLEMS

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

62000000039060

Principal Display Panel

NDC: 0135-5023-01

new

SENSODYNE

WITH FLUORIDE

SENSITIVITY & GUM

IMPROVES GUM HEALTH

MINT

LOW ABRASION FORMULA

DUAL ACTION TOOTHPASTE

TOOTHPASTE FOR SENSITIVE TEETH, GINGIVITIS AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4 g)

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Sensitivity & Gum?

Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity & improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.

SENSITIVE AREAS AND SWOLLEN BLEEDING GUMS

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS

TARGETS & HELPS REMOVE PLAQUE BACTERIA

RELIEVES TOOTH SENSITIVITY* & IMPROVES GUM HEALTH

*with twice daily brushing

Dual Action forTOOTH SENSITIVITY & GUM PROBLEMS

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

62000000039090

INGREDIENTS AND APPEARANCE

SENSODYNE  SENSITIVITY AND GUM MINT
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-5023
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, UNSPECIFIED FORM (UNII: 5HK03SA80J)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
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: 0135-5023-01	1 in 1 CARTON	01/06/2020
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-5023-02	1 in 1 CARTON	01/06/2020
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	01/06/2020

SENSODYNE  SENSITIVITY AND GUM WHITENING
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-5024
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, UNSPECIFIED FORM (UNII: 5HK03SA80J)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
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: 0135-5024-01	1 in 1 CARTON	01/06/2020
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-5024-02	1 in 1 CARTON	01/06/2020
2		65.2 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	01/06/2020

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