SENSODYNE PRONAMEL GENTLE WHITENING FRESH MINT- 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)

Purposes

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

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

• do not store above 25°C (77°F)

Inactive ingredients

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

Questions or comments?

1-866-844-2797

Additional information

ALWAYS FOLLOW THE LABEL

SENSODYNE PRONAMEL

Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

ACID ATTACKS ENAMEL

WEAKENING THE ENAMEL STRUCTURE

PRONAMEL REBUILDS & RESTORES ENAMEL

FOR STRONG HEALTHY TEETH

Healthy white teeth start with strong enamel.

Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

With twice-daily brushing, Pronamel helps to:

Rebuild enamel strength for strong, healthy teeth

Protect against the effects of dietary acids

Relieve sensitive teeth

Freshen breath

Protect against cavities

Recycle Carton, Tube and Cap
Save Water

Turn off tap while brushing

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

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

©2022 GSK group of companies or its licensor.

Principal Display Panel

SENSODYNE

PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Fresh Mint

GENTLE WHITENING

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

NET WT 4.0 OZ (113 g)

62000000079590 Front Carton

INGREDIENTS AND APPEARANCE

SENSODYNE PRONAMEL  GENTLE WHITENING FRESH MINT
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0644
Route of Administration	DENTAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0644-01	1 in 1 CARTON	04/03/2023
1		113 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 Drug	M022	04/03/2023

Labeler - Haleon US Holdings LLC (079944263)