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Sensodyne by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Medically reviewed on June 23, 2016

Dosage form: gel
Ingredients: POTASSIUM NITRATE 50mg in 1g, SODIUM FLUORIDE 1.5mg 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 0.15% 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

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 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)

Inactive ingredients

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 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0550-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Full Protection + WHITENING

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

NET WT 4.0 oz (113g)

©2012 GlaxoSmithKline

102038XA

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

NET WT 4.0 oz (113g)

©2013 GlaxoSmithKline

102039XB

SENSODYNE 
potassium nitrate and sodium fluoride gel
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 ION1.5 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
Color    Score    
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 gel
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 ION1.5 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
Color    Score    
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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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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