SENSODYNE- potassium nitrate and sodium fluoride 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)

**maximum FDA sensitivity active ingredient

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 of age: Consult a dentist or doctor.

Other information

• store below 30ºC (86ºF)

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, sodium hydroxide, cocamidopropyl betaine, sodium saccharin, blue 1

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC: 0135-0593-01

SENSODYNE®

Deep Clean

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MAXIMUM STRENGTH** WITH FLORIDE

24/7 SENSITIVITY PROTECTION*

#1 Dentist Recommended Brand†

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

Advanced Cleaning & Lasting Freshness

NET WT4.0 OZ (113 g)

#1 Dentist Recommended Brand for Sensitive Teeth†

†Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a “shield of protection” against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

• Long lasting sensitivity protection*
• Foam boost technology
• Provides all the benefits of a regular fluoride toothpaste*

*with twice daily brushing

**maximum FDA sensitivity active ingredient

This product contains no sugar.

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

BEFORE

Sensitivity starts with exposed dentin. Sensitive teeth need special care.

24 hr PROTECTION*

AFTER

Sensodyne Deep Clean works inside the tooth to help calm the nerves for 24hr sensitivity protection.*

GSK Consumer Healthcare

Warren, NJ 07059

©2016 GSK group of companies or its licensor. All rights reserved.

1-866-844-2797

105470XB

INGREDIENTS AND APPEARANCE

SENSODYNE 
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0593
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)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0593-01	1 in 1 CARTON	12/19/2016
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0593-02	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

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