Label: LEADER NICOTINE TRANSDERMAL SYSTEM STEP 1- nicotine patch, extended release
LEADER NICOTINE TRANSDERMAL SYSTEM STEP 2- nicotine patch, extended release
LEADER NICOTINE TRANSDERMAL SYSTEM STEP 3- nicotine patch, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-358-74, 37205-361-74, 37205-363-74 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 2, 2012
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient Step 1
- Purpose
- Uses
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Warnings
If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children and pets
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Directions
- If you are under 18 years of age, ask a doctor before use
- before using this product, read the enclosed self-help guide for complete directions and other information
- stop smoking completely when you begin using the patch
- if you smoke more than 10 cigarettes per day, use the following schedule below:
- if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop
- apply one new patch every 24 hours on skin that is dry, clean and hairless
- remove backing from patch and immediately press onto skin. Hold for 10 seconds.
- wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.
- the used patch should be removed and a new one applied to a different skin site at the same time each day
- if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
- do not wear more than one patch at a time
- do not cut patch in half or into smaller pieces
- do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
- to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures
- stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.
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Other information
● store at 20-25°C (68-77°F)
USER'S GUIDE
USER’S GUIDE
Nicotine Transdermal System
STOP SMOKING AID PATCH
HABITROL TAKE CONTROL SUPPORT PROGRAM® (with logo)
Your guide to help you successfully quit smoking
Table of Contents
I: Thinking About Quitting
Why the HABITROL Take Control® Support Program Leads to Success ….... 3
Working Towards Success: The Stages of Change ........................................... 5
Which Way Now? ............................................................................................ 8
Why I Want to Stop Smoking ........................................................................... 8
Health Benefits of Quitting ...............................................................................II: Getting Started: Your Personal Quit Plan
Setting Your Quit Date ..................................................................................... 10
Understanding Nicotine Addiction ................................................................... 10
Smoking and Your Body ................................................................................. 10
Smoking and Your Mind ................................................................................. 11
Knowing Your Triggers ................................................................................... 12Taming Your Triggers ...................................................................................... 12
Reducing the Urge to Smoke ........................................................................... 12
Building Your Supporting Cast ....................................................................... 14
Countdown to Quit Day: 10 Steps to Success ................................................. 15
Rewarding Yourself ....................................................................................... 16
If You Slip ..................................................................................................... 16
III: The Patch
Important Information About this Nicotine Transdermal System ................... 18
How the Patch Works .................................................................................... 19
How to Use the Patch .................................................................................... 20
IV: Weight Control Guide .......................................................................... 27
V: You Are on Your Way ......................................................................... 29
VI: Your Daily Success Calendar ............................................................. 30
VII: HABITROL Take Control® Support Program Resources ............. 34
My Trigger
(In the past, I smoked ...)
My Solution
(Now, I will ...)
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To concentrate
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To relax
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To give myself a lift
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Because I was angry
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Because I was bored
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Because I felt stressed
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Building Your Supporting Cast
CHECK OFF EACH DAY AS A NONSMOKER AND
WATCH THOSE SUCCESSFUL DAYS ACCUMULATE
*If you smoke 10 or less cigarettes per day, start with the Step 2, 14 mg patch for 6 weeks,then step 3, 7 mg patch for 2 weeks.
CHECK OFF EACH DAY AS A NONSMOKER AND
WATCH THOSE SUCCESSFUL DAYS ACCUMULATE
- Inactive ingredients
- Comments or Questions?
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Additional information
Habitrol Take Control Support Program® (with logo)
Nicotine Transdermal System Patch
STOP SMOKING AID
Includes: Behavior Support Program with self-help guide
TO INCREASE YOUR SUCCESS IN QUITTING:
- You must be motivated to quit.
- Use one patch daily according to directions.
- Complete the full treatment program.
- Do not use patch for more than 8 weeks.
- Use patch with a behavioral support program, such as the one described in the enclosed booklet and on the compact disc.
Pouch Image:
- Step 1Principal Display
- Step 2 Principal Display
- Step 3 Principal Display
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INGREDIENTS AND APPEARANCE
LEADER NICOTINE TRANSDERMAL SYSTEM STEP 1
nicotine patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-358 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 21 mg in 24 h Inactive Ingredients Ingredient Name Strength METHACRYLIC ACID (UNII: 1CS02G8656) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-358-74 14 in 1 CARTON 1 1 in 1 POUCH 1 24 h in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020076 01/02/2012 LEADER NICOTINE TRANSDERMAL SYSTEM STEP 2
nicotine patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-361 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 14 mg in 24 h Inactive Ingredients Ingredient Name Strength METHACRYLIC ACID (UNII: 1CS02G8656) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-361-74 14 in 1 CARTON 1 1 in 1 POUCH 1 24 h in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020076 01/02/2012 LEADER NICOTINE TRANSDERMAL SYSTEM STEP 3
nicotine patch, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-363 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 7 mg in 24 h Inactive Ingredients Ingredient Name Strength METHACRYLIC ACID (UNII: 1CS02G8656) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-363-74 14 in 1 CARTON 1 1 in 1 POUCH 1 24 h in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020076 01/02/2012 Labeler - Cardinal Health (097537435)