Active Ingredients
Potassium nitrate (5%)*
Sodium fluoride (0.15% w/v fluoride ion)
Sensodyne
FDA Label NDC 0135-0528
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Sensodyne (NDC 0135-0528). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, stop use and ask a dentist if, keep out of reach of children., directions, other information, inactive ingredients (cool gel), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
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 directed 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 (Cool Gel)
water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, sodium hydroxide, sucralose, FD&C Blue No. 1
Inactive Ingredients (Extra Whitening)
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
Inactive Ingredients (Fresh Mint)
water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1
Inactive Ingredients (Fresh Impact)
water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, blue 1
Inactive Ingredients (Original)
water, sorbitol, glycerin, hydrated silica, cellulose gum, sodium methyl cocoyl taurate, silica, titanium dioxide, flavor, sodium saccharin, trisodium phosphate, red 28
Questions Or Comments?
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 AND CAVITY PREVENTION
NET WT 4.0 OZ (113g)
#1 Dentist Recommended Brand
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
COOL GEL
FRESH FLAVOR
24/7 SENSITIVITY PROTECTION*
USE SENSODYNE®toothpaste whenever you normally brush:
Clinically proven ingredient reduces painful sensitivity
Provides sensitivity relief in as little as two weeks
Freshens breath with a cool minty flavor
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
SENSODYNE and package design elements are trademarks of the GlaxoSmithKline group of companies.
Visit us at: www.sensodyne.com
This product contains no sugar.
©2013 GlaxoSmithKline
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in the U.S.A.
ALWAYS FOLLOW THE LABEL
102037XB
NDC 0135-0525-09
SENSODYNE®
MAXIMUM STRENGTH** WITH FLUORIDE
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
NET WT 4.0 OZ (113g)
#1 Dentist Recommended Brand
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
Extra Whitening
24/7 SENSITIVITY PROTECTION*
USE SENSODYNE®toothpaste whenever you normally brush:
Clinically proven ingredient reduces painful sensitivity
Provides sensitivity relief in as little as two weeks
Helps to remove stains for a whiter, brighter smile
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
SENSODYNE and package design elements are trademarks of the GlaxoSmithKline group of companies.
Visit us at: www.sensodyne.com
This product contains no sugar.
©2012 GlaxoSmithKline
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in the U.S.A.
ALWAYS FOLLOW THE LABEL
102033XA
NDC 0135-0529-04
SENSODYNE®
MAXIMUM STRENGTH** WITH FLUORIDE
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
NET WT 4.0 OZ (113g)
#1 Dentist Recommended Brand
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
Fresh Mint
24/7 SENSITIVITY PROTECTION*
USE SENSODYNE®toothpaste whenever you normally brush:
Clinically proven ingredient reduces painful sensitivity
Provides sensitivity relief in as little as two weeks
Freshens breath with a fresh minty flavor
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
SENSODYNE and package design elements are trademarks of the GlaxoSmithKline group of companies.
Visit us at: www.sensodyne.com
This product contains no sugar.
©2012 GlaxoSmithKline
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in the U.S.A.
ALWAYS FOLLOW THE LABEL
102028XA
NDC 0135-0528-04
SENSODYNE®
MAXIMUM STRENGTH** WITH FLUORIDE
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
NET WT 4.0 OZ (113g)
#1 Dentist Recommended Brand
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
Fresh Impact®
Keeps Breath Feeling Fresh
24/7 SENSITIVITY PROTECTION*
USE SENSODYNE®toothpaste whenever you normally brush:
Clinically proven ingredient reduces painful sensitivity
Provides sensitivity relief in as little as two weeks
Gives breath a long lasting freshening effect
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
SENSODYNE, FRESH IMPACT and package design elements are trademarks of the GlaxoSmithKline group of companies.
Visit us at: www.sensodyne.com
©2012 GlaxoSmithKline
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
“The ADA Council on Scientific Affairs’ Acceptance of Sensodyne Fresh Impact is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed.”
This product contains no sugar, like all ADA-accepted toothpaste.
ALWAYS FOLLOW THE LABEL
102027XA
NDC 0135-0526-04
SENSODYNE®
MAXIMUM STRENGTH** WITH FLUORIDE
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
NET WT 4.0 OZ (113g)
#1 Dentist Recommended Brand
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
Original Flavor
24/7 SENSITIVITY PROTECTION*
USE SENSODYNE®toothpaste whenever you normally brush:
Clinically proven ingredient reduces painful sensitivity
Provides sensitivity relief in as little as two weeks
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
SENSODYNE and package design elements are trademarks of the GlaxoSmithKline group of companies.
Visit us at: www.sensodyne.com
This product contains no sugar.
©2012 GlaxoSmithKline
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in the U.S.A.
ALWAYS FOLLOW THE LABEL
102036XA
* Please review the disclaimer below.
