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Sensodyne by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Medically reviewed on March 14, 2018

Dosage form: paste
Ingredients: POTASSIUM NITRATE 50mg in 1g, SODIUM FLUORIDE 1.1mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0550

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

Potassium nitrate 5%**

Sodium fluoride 0.24% (0.15% 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 of age: Consult a dentist or doctor.

Other information
store below 30°C (86°F)

Inactiveingredients

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

Questions or comments?

call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0550-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Full Protection + WHITENING

24/7 SENSITIVITY PROTECTION*

#1 Dentist Recommended Brand*

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

NET WT 4.0 OZ (113 g)

USE SENSODYNE® toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity
Provides sensitivity relief in as little as two weeks
Helps maintain healthy gums with regular brushing
Whitens teeth by removing surface stains
Leaves your mouth feeling clean and fresh
Contains fluoride for cavity protection

*#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.

*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.

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

105784XA

Principal Display Panel

NDC 0135-0551-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Tartar Control + WHITENING

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

24/7 SENSITIVTY PROTECTION*

NET WT 4.0 OZ (113 g)

USE SENSODYNE® toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity
Provides sensitivity relief in as little as two weeks
Helps remove tartar build-up above the gum line with regular brushing
Helps whiten teeth by removing surface stains
Leaves your mouth feeling clean and fresh
Contains fluoride for cavity protection

#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.

*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.

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

105748XA

SENSODYNE 
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0550
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM TRIPOLYPHOSPHATE ANHYDROUS 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
COCAMIDOPROPYL BETAINE 
SODIUM METHYL COCOYL TAURATE 
XANTHAN GUM 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SUCRALOSE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0550-041 TUBE in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/17/2004
SENSODYNE 
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0551
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDRATED SILICA 
SORBITOL 
GLYCERIN 
SODIUM TRIPOLYPHOSPHATE ANHYDROUS 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
COCAMIDOPROPYL BETAINE 
SODIUM METHYL COCOYL TAURATE 
XANTHAN GUM 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
SUCRALOSE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0551-041 TUBE in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/02/2002
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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