Label: NICOTINE TRANSDERMAL SYSTEM- nicotine patch, extended release

  • NDC Code(s): 49035-194-01, 49035-194-02, 49035-195-02, 49035-196-02
  • Packager: Wal-Mart Stores Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated March 21, 2024

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

  • 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.
  • Other information

    store at 20 – 25 oC (68 – 77 oF)

  • Inactive ingredients

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

  • Questions or comments?

    call toll-free 1-888-287-1915

    For your family's protection, nicotine patches are supplied in child-resistant pouches.

    Do not use if individual pouch/packet is damaged or open.

    Walmart

    If this product is found for sale at a location other than Walmart please call 1-800-WAL-MART.

    To increase your success in quitting:

    • 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.
    • Not for sale to those 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.

    Free audio CD upon request. See inside.

    Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

    Made in Switzerland

    Distributed by:

    Wal-Mart Stores, Inc.,

    Bentonville, AR 72716

    © Wal-Mart Stores, Inc.

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

    What is the nicotine patch and how is it used?

    The nicotine patch is a small, nicotine-containing patch. When you put on a nicotine patch, nicotine passes through the skin and into your body. The 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

    READ THE LABEL

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-194-02

    Clear

    Nicotine

    Transdermal

    System

    equate®

    Compare to NicoDerm® CQ®*

    21mg Delivered Over 24 hours

    Stop Smoking Aid

    Includes User's Guide with behavior support program enrollment form

    If you smoke more than10 cigarettes per day, start with Step 1

    If you smoke 10 or lesscigarettes per day, start with Step 2

    21 mg

    14 PATCHES

    STEP 1

    100224XA

    Nicotine Clear Patch Walmart 21mg Step 1 carton
  • PRINCIPAL DISPLAY PANEL

     NDC 49035-195-02

    Clear

    Nicotine

    Transdermal

    System

    equate®

    Compare to NicoDerm® CQ®*

    14mg Delivered Over 24 hours

    Stop Smoking Aid

    Includes User's Guide with behavior support program enrollment form

    If you smoke more than10 cigarettes per day, start with Step 1

    If you smoke 10 or lesscigarettes per day, start with Step 2

    14 mg

    14 PATCHES

    STEP 2

    100222XA

    Nicotine Clear Patch Walmart 14mg Step 2 carton
  • PRINCIPAL DISPLAY PANEL

     NDC 49035-196-02

    Clear

    Nicotine

    Transdermal

    System

    equate®

    Compare to NicoDerm® CQ®*

    7mg Delivered Over 24 hours

    Stop Smoking Aid

    Includes User's Guide

    For use after completing Step 2

    If you smoke more than10 cigarettes per day, start with Step 1

    If you smoke 10 or lesscigarettes per day, start with Step 2

    7 mg

    14 PATCHES

    STEP 3

    100352XA

    Nicotine Clear Patch Walmart 7mg Step 3 Carton
  • INGREDIENTS AND APPEARANCE
    NICOTINE   TRANSDERMAL SYSTEM
    nicotine patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-194
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE21 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-194-0214 in 1 CARTON10/19/2010
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:49035-194-017 in 1 CARTON10/19/2010
    224 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02016510/19/2010
    NICOTINE   TRANSDERMAL SYSTEM
    nicotine patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-195
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-195-0214 in 1 CARTON10/19/2010
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02016510/19/2010
    NICOTINE   TRANSDERMAL SYSTEM
    nicotine patch, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-196
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE7 mg  in 24 h
    Inactive Ingredients
    Ingredient NameStrength
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-196-0214 in 1 CARTON10/19/2010
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02016510/19/2010
    Labeler - Wal-Mart Stores Inc (051957769)