SENSODYNE PRONAMEL GENTLE WHITENING ADVANCED- 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 Haleon US Holdings 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, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

Questions or comments?

1-866-844-2797

Generic Section

SENSODYNE PRONAMEL

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.

ACID ATTACKS ENAMEL

WEAKENING THE ENAMEL STRUCTURE

PRONAMEL REBUUILDS & RESTORES ENAMEL

FOR STRONG HEALTHY TEETH

Does not contain: SLS/sulfates artificial dyes parabens triclosan peroxide

* removes stains

ALWAYS FOLLOW THE LABEL

CARTON RECYCLE

TUBE RECYCLE

CAP† CHECK LOCALLY

† Recycling facilities for the cap may not exist in your area

Save Water

Turn off tap while brushing

Recyclable Packaging

Recyclable Carton

Recyclable Tube & Cap†

SPECIALIST ENAMEL PROTECTION

The acids in your diet can damage tooth enamel, leading to dull, yellow teeth.

Wine Acids

Fruit Acids

Soda Acids

Pronamel strengthens acid weakened enamel and protects teeth from these acids, keeping teeth strong, healthy and white.

SENSODYNE PRONAMEL

POWERFUL WHITENING*

GENTLE ON ENAMEL

#1 DENTIST RECOMMENDED ENAMEL BRAND

Principal Display Panel

4 PACK

SENSODYNE PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

Alpine Breeze

GENTLE WHITENING

ADVANCED

POWERFUL WHITENING*,

GENTLE ON ENAMEL

4 TUBES OF 6.5 OZ (184 g) EACH – TOTAL NET WT 26 OZ (736 g)

INGREDIENTS AND APPEARANCE

SENSODYNE PRONAMEL  GENTLE WHITENING ADVANCED
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0580
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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
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	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0580-01	1 in 1 CARTON	03/15/2021
1		184 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0580-02	4 in 1 CARTON	07/01/2023
2		184 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	03/15/2021

Labeler - Haleon US Holdings LLC (079944263)