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Sensodyne True white

Dosage form: paste
Ingredients: POTASSIUM NITRATE 50mg in 1g, SODIUM FLUORIDE 1.6mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0135-0581

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 ingredient

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 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

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®

New

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MINT

Sensitivity Relief*

Stain Prevention • Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

NET WT 3.0 OZ (85g)

Brushing with abrasive toothpaste wears 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

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

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

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

**maximum FDA sensitivity active ingredient

ALWAYS FOLLOW THE LABEL

104928XB

Principal Display Panel

NDC 0135-0579-01

SENSODYNE®

TRUE

white®

New

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

EXTRA FRESH

Sensitivity Relief*

Stain Prevention • Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

NET WT 3.0 OZ (85g)

Brushing with abrasive toothpaste wears 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

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

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

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

**maximum FDA sensitivity active ingredient

ALWAYS FOLLOW THE LABEL

104929XB

SENSODYNE  TRUE WHITE
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0581
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 ION1.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
GLYCERIN 
HYDRATED SILICA 
SODIUM TRIPOLYPHOSPHATE ANHYDROUS 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
SODIUM METHYL COCOYL TAURATE 
COCAMIDOPROPYL BETAINE 
XANTHAN GUM 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0581-011 TUBE in 1 CARTON
185 g in 1 TUBE
2NDC:0135-0581-021 TUBE in 1 CARTON
223 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/21/2015
SENSODYNE  TRUE WHITE
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0579
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 ION1.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
GLYCERIN 
HYDRATED SILICA 
SODIUM TRIPOLYPHOSPHATE ANHYDROUS 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
SODIUM METHYL COCOYL TAURATE 
COCAMIDOPROPYL BETAINE 
XANTHAN GUM 
SODIUM HYDROXIDE 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (extra fresh) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0579-011 TUBE in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/21/2015
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2016
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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