SENSODYNE REPAIR AND PROTECT- stannous fluoride paste SENSODYNE REPAIR AND PROTECT EXTRA FRESH- stannous fluoride paste SENSODYNE REPAIR AND PROTECT 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, 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 product 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 30°C (86°F)

Inactive ingredients (Regular)

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

Inactive ingredients (Extra Fresh)

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

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC: 0135-0548-02

SENSODYNE

WITH FLUORIDE

DAILY REPAIR* TOOTHPASTE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4g)

#1 Dentist Recommended Brand for Sensitive Teeth

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

SENSODYNE REPAIR & PROTECT

Proven relief and protection from sensitivity pain*

Daily protection for sensitive teeth*

Contains fluoride for cavity protection

Helps keep breath minty fresh

Helps whiten enamel

Exposed dentin

Repairing layer protects against sensitivity*

Sensodyne Repair and Protect toothpaste helps repair* the sensitive areas of your teeth.

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Repair and Protect?

Now there is a Sensodynetoothpaste that can help repair sensitive areas of your teeth. The active ingredient in Sensodyne Repair & Protect acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. It is also specially formulated to help whiten enamel and prevent staining. With regular use, Sensodyne Repair Protect provides proven relief from sensitivity*.

*With twice daily brushing

ALWAYS FOLLOW THE LABEL

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

©2018 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

102432XD

Principal Display Panel

NDC: 0135-0547-02

SENSODYNE

WITH FLUORIDE

DAILY REPAIR* TOOTHPASTE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4g)

#1 Dentist Recommended Brand for Sensitive Teeth

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

SENSODYNE REPAIR & PROTECT

EXTRA FRESH

Proven relief and protection from sensitivity pain*

Daily protection for sensitive teeth*

Contains fluoride for cavity protection

Leaves your mouth feeling clean and fresh

Helps whiten enamel

Exposed dentin

Repairing layer protects against sensitivity*

Sensodyne Repair and Protect toothpaste helps repair* the sensitive areas of your teeth.

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Repair and Protect?

Now there is a Sensodyne toothpaste that can help repair* sensitive areas of your teeth. The active ingredient in Sensodyne Repair & Protect acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. It is also specially formulated to help whiten enamel and prevent staining. With regular use, Sensodyne Repair Protect provides proven relief from sensitivity*.

*With twice daily brushing

ALWAYS FOLLOW THE LABEL

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

©2018 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

102433XD

Principal Display Panel

NDC: 0135-0575-01

SENSODYNE

WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

REPAIR & PROTECT

WHITENING

NET WT 3.4 OZ (96.4g)

DAILY REPAIR* TOOTHPASTE

#1 Dentist Recommended Brand for Sensitive Teeth

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

SENSODYNE REPAIR & PROTECT WHITENING

Proven relief and protection from sensitivity pain*

Daily protection for sensitive teeth*

Helps to remove stains for whiter teeth

Contains fluoride for cavity protection

Helps keep breath minty fresh

Exposed Dentin

Repairing Layer protects against sensitivity*

Sensodyne Repair and Protect toothpaste helps repair* the sensitive areas of your teeth.

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Repair and Protect Whitening toothpaste?

Sensodyne Repair & Protect toothpaste helps repair sensitive areas of your teeth. The active ingredient in Sensodyne Repair & Protect Whitening toothpaste acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. It is also specially formulated to whiten enamel and prevent staining. With regular use, SensodyneRepair Protect Whitening toothpaste provides proven relief from sensitivity*.

*With twice daily brushing

ALWAYS FOLLOW THE LABEL

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

©2018 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

104340XC

INGREDIENTS AND APPEARANCE

SENSODYNE  REPAIR AND PROTECT
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0548
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)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0548-02	1 in 1 CARTON	02/04/2013
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0548-01	1 in 1 CARTON	02/04/2013
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	02/04/2013

SENSODYNE  REPAIR AND PROTECT EXTRA FRESH
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0547
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)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0547-02	1 in 1 CARTON	02/04/2013
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	02/04/2013

SENSODYNE  REPAIR AND PROTECT WHITENING
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0575
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)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0575-01	1 in 1 CARTON	01/19/2015
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	01/19/2015

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