Nicotine Patch

Drug Facts

Active ingredient Step 1 (in each patch)

Nicotine, 21mg delivered over 24 hours

Active ingredient Step 2 (in each patch)

Nicotine, 14mg delivered over 24 hours

Active ingredient Step 3 (in each patch)

Nicotine, 7mg delivered over 24 hours

Purpose

Stop smoking aid

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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

• If you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products

Ask a doctor before use if you have

• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.


• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.


• an allergy to adhesive tape or have skin problems because you are more likely to get rashes

Ask a doctor or pharmacist before use if you are

• using a non-nicotine stop smoking drug


• taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

When using this product

• do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch.


• If you have vivid dreams or other sleep disturbances remove this patch at bedtime

Stop use and ask a doctor if

• skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash


• irregular heartbeat or palpitations occur


• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness, and rapid heartbeat

Keep out of reach of children and pets.

Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

Directions

• if you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed User’s 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 according to the following 10-week schedule:


• 
  
  
  
  
  
  
  
  
  
  

  STEP 1	STEP 2	STEP 3
  Use one 21mg patch/day	Use one 14mg patch/day	Use one 7mg patch/day
  Weeks 1-6	Weeks 7-8	Weeks 9-10

• if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop.


• steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.


• apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.


• remove backing from patch and immediately press onto skin. Hold for 10 seconds.


• wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling.


• you may wear the patch for 16 or 24 hours.


• if you crave cigarettes when you wake up, wear the patch for 24 hours.


• if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning


• the used patch should be removed and a new one applied to a different skin site at the same time each day


• 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


• stop using the patch at the end of 10 weeks. If you started with STEP 2, stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.

Inactive ingredients

ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

Other information

store at 20 – 25oC (68 – 77oF)

Made in Switzerland

See top panel for lot number and expiration date.

*NICODERM is a licensed trademark of the GlaxoSmithKline group of companies.

Questions and comments?

call toll-free 1-877-306-0019

(English/Spanish) weekdays (9:00 a.m. – 4:30 p.m. ET)

Principal Display Panel

NDC 0363-0194-02

CLEAR Nicotine Transdermal System Patch

Walgreens

STEP 1

21mg delivered over 24 hours

14 Clear Patches

2 WEEK KIT

STOP SMOKING AID

with Behavior Support Program

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

Compare to NicoDerm® CQ®*

Principal Display Panel

NDC 0363-0195-02

CLEAR Nicotine Transdermal System Patch

Walgreens

STEP 2

14mg delivered over 24 hours

14 Clear Patches

2 WEEK KIT

STOP SMOKING AID

with Behavior Support Program

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

Compare to NicoDerm® CQ®*

Principal Display Panel

NDC 0363-0196-02

CLEAR Nicotine Transdermal System Patch

Walgreens

STEP 3

7mg delivered over 24 hours

14 Clear Patches

2 WEEK KIT

STOP SMOKING AID

with Behavior Support Program

For use after completing Step 2

Compare to NicoDerm® CQ®*

NICOTINE  TRANSDERMAL SYSTEM nicotine  patch, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0363-0194 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 21 mg

Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE   ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0363-0194-02 14 PATCH In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020165	02/15/2010

NICOTINE  TRANSDERMAL SYSTEM nicotine  patch, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0363-0195 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 14 mg

Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE   ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0363-0195-02 14 PATCH In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020165	02/15/2010

NICOTINE  TRANSDERMAL SYSTEM nicotine  patch, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0363-0196 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 7 mg

Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE   ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0363-0196-02 14 PATCH In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020165	02/15/2010

Labeler - Walgreens (008965063)

Revised: 02/2010Walgreens

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