SENSODYNE TRUE WHITE- 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 ingredients

Potassium nitrate 5%**

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

Inactive ingredients

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

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC: 0135-0581-01

SENSODYNE®

TRUE

white®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MINT

Sensitivity Relief*

Stain Prevention Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

FOR SENSITIVE TEETH

NET WT 3.0 OZ (85 g)

Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne® True White® has the lowest abrasion formulation ever in a Sensodyne® toothpaste.

With twice daily brushing it:

• is proven to relieve sensitivity pain
• helps to gently whiten your teeth
• leaves a protective shield to help prevent new stains forming
• freshens breath, fights cavities and helps keep gums healthy

*with twice daily brushing

**maximum FDA sensitivity active ingredient

GSK Consumer Healthcare

Warren, NJ 07059

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

©2015 GSK group of companies or its licensor. All rights reserved

ALWAYS FOLLOW THE LABEL

105639XA

Principal Display Panel

NDC: 0135-0579-01

SENSODYNE®

TRUE

white®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

EXTRA FRESH

Sensitivity Relief*

Stain Prevention Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

FOR SENSITIVE TEETH

NET WT 3.0 OZ (85 g)

Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne® True White® has the lowest abrasion formulation ever in a Sensodyne® toothpaste.

With twice daily brushing it:

• is proven to relieve sensitivity pain
• helps to gently whiten your teeth
• leaves a protective shield to help prevent new stains forming
• freshens breath, fights cavities and helps keep gums healthy

*with twice daily brushing

**maximum FDA sensitivity active ingredient

GSK Consumer Healthcare

Warren, NJ 07059

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

©2015 GSK group of companies or its licensor. All rights reserved.

ALWAYS FOLLOW THE LABEL

105640XA

INGREDIENTS AND APPEARANCE

SENSODYNE  TRUE WHITE
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0581
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
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0581-01	1 in 1 CARTON	12/21/2015
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0581-02	1 in 1 CARTON	12/21/2015
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	12/21/2015

SENSODYNE  TRUE WHITE
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0579
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
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (extra fresh)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0579-01	1 in 1 CARTON	12/21/2015
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	12/21/2015

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