Label: NICOTINE TRANSDERMAL SYSTEM- nicotine kit

  • NDC Code(s): 43598-445-28, 43598-445-56
  • Packager: Dr. Reddy's Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 3, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient Step 1 (in each patch)

    Nicotine, 21 mg delivered over 24 hours

  • Active ingredient Step 2 (in each patch)

    Nicotine, 14 mg delivered over 24 hours

  • Active ingredient Step 3 (in each patch)

    Nicotine, 7 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, use nicotine gum, or use another nicotine patch 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. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

  • 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:

    STEP 1

    STEP 2

    STEP 3

    Use one 21mg patch/day

    Use one 14mg patch/day

    Use one 7mg patch/day

    Weeks 1-4

    Weeks 5-6

    Weeks 7-8

    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.
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive ingredients

    Acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

  • Questions or comments?

    call 1-800-585-8682

    Weekdays (9am-8pm ET) or visit us at www.habitrol.com

    TO INCREASE YOUR SUCCESS IN QUITTING:

    1. You must be motivated to quit.

    2. Use one patch daily according to directions.

    3. It is important to complete treatment.

    4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

    5. Use patch with a behavioural support program, such as the one described in the enclosed booklet.

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

    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.
  • Principal Display Panel Kit

    Nicotine Transdermal SystemPATCH Kit

    Nicotine Patch Kit

  • INGREDIENTS AND APPEARANCE
    NICOTINE   TRANSDERMAL SYSTEM
    nicotine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-445
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43598-445-2856 in 1 CARTON05/14/2015
    1NDC:43598-445-561 in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 3
    Part 1 of 3
    NICOTINE 
    nicotine transdermal system patch, extended release
    Product Information
    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
    Methacrylic Acid (UNII: 1CS02G8656)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007605/14/2015
    Part 2 of 3
    NICOTINE 
    nicotine transdermal system patch, extended release
    Product Information
    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
    Methacrylic Acid (UNII: 1CS02G8656)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007605/14/2015
    Part 3 of 3
    NICOTINE 
    nicotine transdermal system patch, extended release
    Product Information
    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
    Methacrylic Acid (UNII: 1CS02G8656)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007605/14/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007605/14/2015
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)