SENSODYNE ADVANCED WHITENING- potassium nitrate 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

Potassium nitrate 5%

Sodium fluoride 0.25% (0.16% 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 30° C (86 °F)

Inactive ingredients (Advanced Whitening)

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate PEG-8, alumina, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin, sucralose

Questions or comments?

1-866-844-2797

Additional information

ALWAYS FOLLOW THE LABEL

What are sensitive teeth?

Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or

drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity,

for example, with cold and hot food and drinks.

What does Sensodyne do?

Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness.

*with twice daily brushing.

24/7 Sensitivity Protection*

+ Strong & Healthy Teeth

Use Sensodyne Advanced Whitening twice daily:

Long lasting sensitivity protection* every day

Contains fluoride to protect against cavities

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

©2020 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

62000000057087

Principal Display Panel

NDC: 0135-0479-01

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

Advanced Whitening

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

NET WT 6.5 OZ (184 g)

INGREDIENTS AND APPEARANCE

SENSODYNE   ADVANCED WHITENING
potassium nitrate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0479
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)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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: 0135-0479-01	1 in 1 CARTON	10/16/2020
1		184 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0479-02	4 in 1 CARTON	07/03/2023
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	10/16/2020

Labeler - Haleon US Holdings LLC (079944263)