Label: NICOTINE TRANSDERMAL SYSTEM- nicotine patch, extended release

  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 20, 2016

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

  • Active ingredient (in each patch)

    Nicotine, 21 mg 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 21 mg patch/day
    Use one 14 mg patch/day
    Use one 7 mg 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.
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive ingredients

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

  • Questions or comments?

    call toll-free 1-866-255-5205 (English/Spanish) weekdays


    You must be motivated to quit.
    Complete the full treatment program, applying a new patch every day.
    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.
    Nicotine transdermal system 21 mg delivered over 24 hours
    Stop smoking aid
    Not for sale to those under 18 years of age.
    Prrof of age required.
    Not for sale in vending machines or from any source where proof of age cannot be verified.
    Free Audio CD upon request. See inside.
    What is the Nicotine Patch and How is it Used?
    Nicotine Patch is a small, nicotine-containing patch. When you put on a Nicotine Patch, nicotine passes through the skin and into your body. Nicotine Patch is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 24 or 16-hour period you wear the Nicotine Patch. This helps to reduce cravings you may have for nicotine.
    Read carton and enclosed User’s Guide before using this product. Keep the carton and User’s Guide. They contain important information.
    Simply Right is dedicated to providing healthful, gentle, and safe personal care products for the entire family. We continuously strive to be your trusted partner in wellness and exceed your expectations.
    We would like to hear from you with any comments or suggestions. In the continental US or Canada, you can call us toll-free at 1-800-255-5205, Monday through Friday, from 8 am to 5 pm CST. Or you can send us an email at
    Distributed by:
    SAM’S West, Inc.
    Bentonville, AR 72716
    *NICODERM is a licensed trademark of the GlaxoSmithKline group of companies.
    Made in Switzerland
    Send comments/questions to:
    GCSP 5.4376.4C
    Consumer Relations
    P.O. Box 13398
    Research Triangle Park, NC 27709-9627
  • Principal Display Panel

    NDC 68196-194-03

    nicotine patch

    Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid

    21 mg


    Health Care

    Compare to NicoDerm®CQ®*

    Includes behavior support program enrollment form & user’s guide

    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

    step 1

    21 clear patches



    101775XA Nicotine Patch Sams 21 mg 21 ct carton
    nicotine patch, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-194
    Route of Administration TRANSDERMAL
    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
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68196-194-03 21 in 1 CARTON 03/02/2012
    1 24 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020165 03/02/2012
    Labeler - Sam's West Inc (051957769)
    Registrant - sanofi-aventis U.S. LLC (011330557)