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Sensodyne

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Potassium nitrate (5%)*

Sodium fluoride (0.15% w/v fluoride ion)

Antihypersensitivity

Anticavity

  • •builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • •aids in the prevention of dental cavities

Stop use and ask a dentist if

  • •the problem persist 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.

  • 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 one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
  • children under 12 years of age: consult a dentist or physician
  • •store below 30°C (86°F)

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

call toll-free 1-866-844-2797 (English/Spanish) weekdays

Principal Display Panel

NDC 10158-985-50

SENSODYNE ®

MAXIMUM STRENGTH* WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

FULL PROTECTION ®

Plus WHITENING

 NET WT 4.0 OZ (113G)

Relieves Painful Sensitivity

Use Sensodyne® whenever you normally brush:

It contains Potassium Nitrate clinically proven to reduce painful sensitivity

It provides sensitivity relief in as little as two weeks

It has fluoride for cavity protection

It fights tartar and plaque build-up above the gum line with regular brushing

Its great taste keeps mouth feeling fresh and clean

It whitens teeth by removing surface stains

#1 Dentist Recommended Brand for Sensitive Teeth†

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

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

*maximum FDA sensitivity active ingredient

SENSODYNE, Rx SENSODYNE 2X A DAY EVERY DAY and device are registered trademarks of the GlaxoSmithKline group of companies.

Visit us at:

www.sensodyne.com

This product contains no sugar.

©2011 GlaxoSmithKline

101291XA

Principal Display Panel

NDC 10158-085-04

SENSODYNE ®

MAXIMUM STRENGTH* WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

TARTAR CONTROL 

Plus WHITENING

 NET WT 4.0 OZ (113G)

Relieves Painful Sensitivity

Use Sensodyne® whenever you normally brush:

It contains Potassium Nitrate clinically proven to reduce painful sensitivity

It provides sensitivity relief in as little as two weeks

It has fluoride for cavity protection

Its great taste keeps mouth feeling fresh and clean

#1 Dentist Recommended Brand for Sensitive Teeth†

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

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

*maximum FDA sensitivity active ingredient

SENSODYNE, Rx SENSODYNE 2X A DAY EVERY DAY and device are registered trademarks of the GlaxoSmithKline group of companies.

Visit us at:

www.sensodyne.com

This product contains no sugar.

©2011 GlaxoSmithKline

101288XA

Sensodyne

potassium nitrate and sodium fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10158-985
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE NITRATE ION 50 mg
SODIUM FLUORIDE FLUORIDE ION 1.5 mg

Inactive Ingredients

Ingredient Name Strength
water
HYDRATED SILICA
sorbitol
GLYCERIN
SODIUM TRIPOLYPHOSPHATE
polyethylene glycol 400
titanium dioxide
COCAMIDOPROPYL BETAINE
SODIUM METHYL COCOYL TAURATE
XANTHAN GUM
SODIUM HYDROXIDE
saccharin sodium
Sucralose

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:10158-985-50 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-06-08


Sensodyne

potassium nitrate and sodium fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10158-085
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POTASSIUM NITRATE NITRATE ION 50 mg
SODIUM FLUORIDE FLUORIDE ION 1.5 mg

Inactive Ingredients

Ingredient Name Strength
water
HYDRATED SILICA
sorbitol
GLYCERIN
SODIUM TRIPOLYPHOSPHATE
polyethylene glycol 400
titanium dioxide
COCAMIDOPROPYL BETAINE
SODIUM METHYL COCOYL TAURATE
XANTHAN GUM
SODIUM HYDROXIDE
saccharin sodium
Sucralose

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:10158-085-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-06-08


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