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  5. Label Information: Sensodyne Fresh Impact

FDA Label for Sensodyne Fresh Impact

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. STOP USE AND ASK A DENTIST IF
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS (COOL GEL)
    9. INACTIVE INGREDIENTS (EXTRA WHITENING)
    10. INACTIVE INGREDIENTS (FRESH MINT)
    11. INACTIVE INGREDIENTS (FRESH IMPACT)
    12. INACTIVE INGREDIENTS (ORIGINAL)
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Sensodyne Fresh Impact Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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.