SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL MINT- potassium nitrate and sodium fluoride paste SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL EXTRA FRESH- potassium nitrate and sodium fluoride paste

Sensodyne Pronamel by

Drug Labeling and Warnings

Sensodyne Pronamel 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%

Sodium fluoride 0.25% (0.15% 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 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:

  Consult a dentist or doctor.

Other information

store below 25°C (77°F)

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC: 0135-0602-01

SENSODYNE

PRONAMEL

STRONG & Bright

ENAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

STRONG ENAMEL

WHITER TEETH*

MINT

No. 1 DENTIST RECOMMENDED BRAND

FOR STRENGTHENING AND PROTECTING ENAMEL

*vs. ProNamel Daily Protection

NET WT 3.0 OZ (85 g)

Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

Sensodyne ProNamel STRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

*vs. ProNamel Daily Protection

With twice daily brushing, the dual action formulation:

• Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
• Polishes away stains for WHITER BRIGHTER TEETH.

FRESHENS breath and fights CAVITIES

GSK Consumer Healthcare

Warren, NJ 07059

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

©2017 GSK group of companies or its licensor

ALWAYS FOLLOW THE LABEL

105491XC

Principal Display Panel

NDC: 0135-0603-01

SENSODYNE

PRONAMEL

STRONG & Bright

ENAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

STRONG ENAMEL

WHITER TEETH*

EXTRA FRESH

No. 1 DENTIST RECOMMENDED BRAND

FOR STRENGTHENING AND PROTECTING ENAMEL

*vs. ProNamel Daily Protection

NET WT 3.0 OZ (85 g)

Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

Sensodyne ProNamelSTRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

*vs. ProNamel Daily Protection

With twice daily brushing, the dual action formulation:

• Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
• Polishes away stains for WHITER BRIGHTER TEETH.

FRESHENS breath and fights CAVITIES

GSK Consumer Healthcare

Warren, NJ 07059

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

©2017 GSK group of companies or its licensor.

ALWAYS FOLLOW THE LABEL

105488XC

INGREDIENTS AND APPEARANCE

SENSODYNE PRONAMEL  STRONG AND BRIGHT ENAMEL MINT
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0602
Route of Administration	ORAL

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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0602-01	1 in 1 CARTON	12/19/2016
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0602-02	1 in 1 CARTON	12/19/2016
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	12/19/2016

SENSODYNE PRONAMEL  STRONG AND BRIGHT ENAMEL EXTRA FRESH
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0603
Route of Administration	ORAL

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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0603-01	1 in 1 CARTON	12/19/2016
1		85 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	12/19/2016

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