Sensodyne description, usages, side effects, indications, overdosage, supplying and lots more!

Sensodyne

GlaxoSmithKline Consumer Healthcare LP

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Potassium nitrate (5%)*

Sodium fluoride (0.15% w/v fluoride ion)

Potassium nitrate (5%)*

Sodium fluoride (0.13% 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, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, blue 1

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

water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, blue 1

Water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1

cellulose gum, D&C red no. 28, flavor, glycerin, hydrated silica, silica, sodium methyl cocoyl taurate, sodium saccharin, sorbitol, titanium dioxide, trisodium phosphate, water

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

Principal Display Panel

NDC 0135-0527-04

SENSODYNE ®

MAXIMUM STRENGTH* WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

COOL GEL

FRESH FLAVOR

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 fast relief in as little as two weeks

It has fluoride for cavity protection

It keeps breath feeling fresh for hours

#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 sensitivity. And, since Sensodyne ® has fluoride, it helps protect against cavities too.

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108, Made in the U.S.A.

*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

100855XA

Principal Display Panel

NDC 0135-0525-09

SENSODYNE ®

MAXIMUM STRENGTH* WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

EXTRA WHITENING

NET WT 4.0 OZ (113G)

Relieves Painful Sensitivity

Use Sensodyne ® whenever you normally brush:

It is clinically proven to reduce painful sensitivity

It provides relief in as little as two weeks

It helps to remove stains for whiter teeth

It has fluoride for cavity protection

Its improved taste keeps mouth feeling fresh & 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 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 everyday® and device are registered trademarks of the GlaxoSmithKline group of companies.

Visit us at:

www.sensodyne.com

This product contains no sugar.

©2010 GlaxoSmithKline

28568XE

Principal Display Panel

NDC 0135-0528-04

SENSODYNE ®

MAXIMUM STRENGTH* WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

FRESH IMPACT ®

KEEPS BREATH FEELING FRESH

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 relief in as little as two weeks

It has fluoride for cavity protection

Its formula keeps breath feeling fresh

It has a great tasting mint flavor

#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 sensitivity. And, since Sensodyne ® has fluoride, it helps protect against cavities too.

Visit us at: www.sensodyne.com

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

*maximum FDA sensitivity active ingredient

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

©2011 GlaxoSmithKline

100859XA

Principal Display Panel

NDC 0135-0529-04

SENSODYNE ®

MAXIMUM STRENGTH* WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

FRESH MINT

 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 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 sensitivity. And, since Sensodyne ® has fluoride, it helps protect against cavities too.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108 Made in the U.S.A.

*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

100863XA

Principal Display Panel

NDC 0135-0526-04

SENSODYNE ®

MAXIMUM STRENGTH* WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

ORIGINAL FLAVOR

 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 fast relief within 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.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108 Made in the U.S.A.

*maximum FDA sensitivity active ingredient

Sensodyne ® and Pronamel ™ are trademarks of the GlaxoSmithKline group of companies.

Visit us at:

www.sensodyne.com

product contains no sugar

©2007 GlaxoSmithKline

28588XB

Sensodyne

potassium nitrate and sodium fluoride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0527
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
sorbitol
HYDRATED SILICA
GLYCERIN
COCAMIDOPROPYL BETAINE
XANTHAN GUM
titanium dioxide
saccharin sodium
SODIUM HYDROXIDE
Sucralose
FD&C BLUE NO. 1

Product Characteristics

Color
BLUE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:0135-0527-04 1 in 1 CARTON

Marketing Information

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


Sensodyne

potassium nitrate and sodium fluoride PASTE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0525
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
SODIUM METHYL COCOYL TAURATE
COCAMIDOPROPYL BETAINE
XANTHAN GUM
SODIUM HYDROXIDE
saccharin sodium
Sucralose

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 23 in 1 TUBE
2 77 in 1 TUBE
3 113 in 1 TUBE
4 170 in 1 TUBE
5 184 in 1 TUBE
6 150 in 1 TUBE
7 113 in 1 TUBE
8 184 in 1 TUBE
9 NDC:0135-0525-08 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:0135-0528
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
sorbitol
HYDRATED SILICA
GLYCERIN
COCAMIDOPROPYL BETAINE
XANTHAN GUM
titanium dioxide
saccharin sodium
SODIUM HYDROXIDE
Sucralose
FD&C BLUE NO. 1

Product Characteristics

Color
WHITE (white and blue)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 23 in 1 TUBE
2 113 in 1 TUBE
3 77 in 1 TUBE
4 NDC:0135-0528-05 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:0135-0529
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
sorbitol
HYDRATED SILICA
GLYCERIN
COCAMIDOPROPYL BETAINE
XANTHAN GUM
titanium dioxide
saccharin sodium
SODIUM HYDROXIDE
Sucralose
D&C YELLOW NO. 10
FD&C BLUE NO. 1

Product Characteristics

Color
GREEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 170 in 1 TUBE
2 77 in 1 TUBE
3 113 in 1 TUBE
4 184 in 1 TUBE
5 150 in 1 TUBE
6 NDC:0135-0529-09 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:0135-0526
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 1.3 mg

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
D&C RED NO. 28
GLYCERIN
HYDRATED SILICA
SILICON DIOXIDE
SODIUM METHYL COCOYL TAURATE
saccharin sodium
sorbitol
titanium dioxide
SODIUM TRIPOLYPHOSPHATE
water

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:0135-0526-04 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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Be sure to consult your doctor before taking any medication!
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