Label: NICOTINE TRANSDERMAL SYSTEM- nicotine patch, extended release 

  • NDC Code(s): 0363-0195-02, 0363-0196-02, 0363-9180-01, 0363-9180-02
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/13

If you are a consumer or patient please visit this version.

  • Active ingredient Step 1 (in each patch)

    Nicotine, 21mg delivered over 24 hours

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  • Active ingredient Step 2 (in each patch)

    Nicotine, 14mg delivered over 24 hours

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  • Active ingredient Step 3 (in each patch)

    Nicotine, 7mg delivered over 24 hours

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  • Purpose

    Stop smoking aid

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  • Use

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

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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

    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.

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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 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.
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  • Other information

    store at 20 – 25oC (68 – 77oF)

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  • Inactive ingredients

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

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  • Questions and comments?

    call toll-free 1-877-306-0019

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

    Compare to NicoDerm® CQ®*

    See top panel for lot number and expiration date.

    *NICODERM and CQ are trademarks of the GlaxoSmithKline group of companies and other third parties.

    Made in Switzerland

    Comments/questions:

    GCSP 5.4376.4C

    Re: Consumer Relations

    PO Box 13398

    Research Triangle Park, NC 27709-9627

    Distributed by:

    Walgreen Co.,

    200 Wilmot Road

    Deerfield, IL 60015-4616

    100% Satisfaction Guaranteed with all Walgreens Products or Your Money Back.

    www.walgreens.com

    TO INCREASE YOUR SUCCESS IN QUITTING:

    1. You must be motivated to quit.

    2. Complete the full treatment program, applying a new patch every day.

    3. Use with a support program as described in the enclosed User's Guide.

    For your family's protection, nicotine patches are supplied in child-resistant pouches. Do not use if individual pouch/packet is damaged or open.

    Not for sale to persons under 18 years of age.
    Proof of age required.
    Not for sale in vending machines or from any source where proof of age cannot be verified.
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  • Principal Display Panel

    NDC 0363-9180-02

    CLEAR Nicotine Transdermal System Patch

    Walgreens

    STEP 1

    21mg delivered over 24 hours

    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

    14 Clear Patches

    2 WEEK KIT

    ©2011

    30818XC

    Walgreens Nicotine Patch 21mg 14ct carton
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  • Principal Display Panel

    NDC 0363-0195-02

    CLEAR Nicotine Transdermal System Patch

    Walgreens

    STEP 2

    14mg delivered over 24 hours

    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

    14 Clear Patches

    2 WEEK KIT

    ©2009

    30819XC

    Nicotine Transdermal System Patch 14 mg Step 2
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  • Principal Display Panel

    NDC 0363-0196-02

    CLEAR Nicotine Transdermal System Patch

    Walgreens

    STEP 3

    7mg delivered over 24 hours

    STOP SMOKING AID

    with Behavior Support Program

    For use after completing Step 2

    14 Clear Patches

    2 WEEK KIT

    ©2009

    30820XA

    Nicotine Transdermal System Patch 7 mg Step 3
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  • INGREDIENTS AND APPEARANCE
    NICOTINE  TRANSDERMAL SYSTEM
    nicotine patch, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-9180
    Route of Administration TRANSDERMAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 21 mg  in 24 h
    Inactive Ingredients
    Ingredient Name Strength
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)  
    HIGH DENSITY POLYETHYLENE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-9180-02 14 in 1 CARTON
    1 24 h in 1 PATCH
    2 NDC:0363-9180-01 7 in 1 CARTON
    2 24 h in 1 PATCH
    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 LABEL Item Code (Source) NDC:0363-0195
    Route of Administration TRANSDERMAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 14 mg  in 24 h
    Inactive Ingredients
    Ingredient Name Strength
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)  
    HIGH DENSITY POLYETHYLENE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0195-02 14 in 1 CARTON
    1 24 h in 1 PATCH
    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 LABEL Item Code (Source) NDC:0363-0196
    Route of Administration TRANSDERMAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NICOTINE (NICOTINE) NICOTINE 7 mg  in 24 h
    Inactive Ingredients
    Ingredient Name Strength
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)  
    HIGH DENSITY POLYETHYLENE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0196-02 14 in 1 CARTON
    1 24 h in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020165 02/15/2010
    Labeler - Walgreen Company (008965063)
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