SENSODYNE COMPLETE PROTECTION- stannous fluoride paste SENSODYNE COMPLETE PROTECTION EXTRA FRESH- stannous fluoride paste

Sensodyne Complete Protection by

Drug Labeling and Warnings

Sensodyne Complete Protection 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 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 may be 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 30°C (86°F)

Inactive ingredients

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

Inactive ingredients (Extra Fresh)

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

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC: 0135-0573-02

SENSODYNE

COMPLETE PROTECTION

WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH, GINGIVITIS AND CAVITY PREVENTION

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

#1 Dentist Recommended Brand for Sensitive Teeth

NET WT 3.4 OZ (96.4 g)

SENSITIVITY

CLEAN

GUMS

FRESH

PLAQUE

ENAMEL

WHITENING

COMPLETE DAILY TOOTHPASTE

SENSODYNE COMPLETE PROTECTION

What is tooth sensitivity?

Sensitivity can be a sign that your teeth are vulnerable, as dentin becomes exposed due to enamel loss or gum recession. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, the nerve inside the tooth can be triggered, causing a short, sharp pain.

FRESH FEELING

PROTECTS ENAMEL

HELPS WHITEN ENAMEL

PROTECTS AGAINST PLAQUE

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TO SHIELD YOU FROM PAIN*

CLEAN FEELING

HELPS PREVENT GINGIVITIS

*With twice daily brushing

Why use Sensodyne Complete Protection toothpaste?

This formulation has been specifically developed to deliver all the toothpaste benefits your sensitive teeth need. Brush twice a day with Sensodyne Complete Protection toothpaste.

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

106355XA

Principal Display Panel

NDC: 0135-0572-02

SENSODYNE

EXTRA FRESH

COMPLETE PROTECTION

TOOTHPASTE FOR SENSITIVE TEETH, GINGIVITIS AND CAVITY PREVENTION

COMPLETE DAILY TOOTHPASTE

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

#1 Dentist Recommended Brand for Sensitive Teeth

NET WT 3.4 OZ (96.4 g)

SENSITIVITY

CLEAN

GUMS

FRESH

PLAQUE

ENAMEL

WHITENING

SENSODYNE COMPLETE PROTECTION

What is tooth sensitivity?

Sensitivity can be a sign that your teeth are vulnerable, as dentin becomes exposed due to enamel loss or gum recession. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, the nerve inside the tooth can be triggered, causing a short, sharp pain.

FRESH FEELING

PROTECTS ENAMEL

HELPS WHITEN ENAMEL

PROTECTS AGAINST PLAQUE

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TO SHIELD YOU FROM PAIN*

CLEAN FEELING

HELPS PREVENT GINGIVITIS

*With twice daily brushing

Why use Sensodyne Complete Protection toothpaste?

This formulation has been specifically developed to deliver all the toothpaste benefits your sensitive teeth need. Brush twice a day with Sensodyne Complete Protection toothpaste.

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

106356XA

INGREDIENTS AND APPEARANCE

SENSODYNE COMPLETE PROTECTION 
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0573
Route of Administration	DENTAL

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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0573-02	1 in 1 CARTON	07/14/2014
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0573-03	1 in 1 CARTON	07/14/2014
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	07/14/2014

SENSODYNE COMPLETE PROTECTION  EXTRA FRESH
stannous fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0572
Route of Administration	DENTAL

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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0572-02	1 in 1 CARTON	07/14/2014
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	07/14/2014

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