FDA Label for Nicotine

View Indications, Usage & Precautions

Nicotine Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services 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 Ingredient Step One (In Each Patch)



Nicotine, 21 mg delivered over 24 hours


Active Ingredient Step Two (In Each Patch)



Nicotine, 14 mg delivered over 24 hours


Active Ingredient Step Three (In Each Patch)



Nicotine, 7 mg delivered over 24 hours


To Increase Your Success In Quitting:



1. You must be motivated to quit.

2. Use one patch daily according to directions.

3. It is important to complete treatment.

4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

5. Use patch with a behavioral support program such as the one described in the enclosed booklet.


Principal Display Panel - Step One 21 Mg Carton



Principal Display Panel - Step 1 – 21 mg Carton Label

McKesson SunMark®

NDC 70677-0032-1

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

21 mg delivered over 24 hours

STOP SMOKING AID

21 mg

Includes Behavior Support Program with Self-Help Guide

STEP ONE

If you smoke MORE than 10 cigarettes per day: Start with Step 1

If you smoke 10 or LESS cigarettes per day: Start with Step 2

14 Patches

*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.


Principal Display Panel - Step Two 14 Mg Carton



Principal Display Panel - Step 2 – 14 mg Carton Label

McKesson SunMark®

NDC 70677-0031-1

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

14 mg delivered over 24 hours

STOP SMOKING AID

14 mg

Includes Behavior Support Program with Self-Help Guide

STEP ONE

If you smoke MORE than 10 cigarettes per day: Start with Step 1

If you smoke 10 or LESS cigarettes per day: Start with Step 2

14 Patches

*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.


Principal Display Panel - Step Three 7 Mg Carton



Principal Display Panel - Step 3 – 7 mg Carton Label

McKesson SunMark®

NDC 70677-0030-1

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

7 mg delivered over 24 hours

STOP SMOKING AID

7 mg

Includes Behavior Support Program with Self-Help Guide

STEP ONE

If you smoke MORE than 10 cigarettes per day: Start with Step 1

If you smoke 10 or LESS cigarettes per day: Start with Step 2

14 Patches

*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.


* Please review the disclaimer below.