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Nicotine transdermal system step 2

nicotine · Nicotine transdermal system step 2 is a cholinergic nicotinic agonist (over-the-counter) containing nicotine, made by Chain Drug Marketing Association INC.

Type
Over the counter
Drug class
Cholinergic Nicotinic Agonist
Route
Transdermal
Manufacturers
1
+ 1 repackager labels

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

Drug facts

Generic name
nicotine
Active ingredients
Nicotine
Dosage forms
Patch, extended release
Label holder
Chain Drug Marketing Association INC
FDA application
NDA020076
Label updated
07/25/2024

Active ingredients

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

Uses

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

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
  • Begin using the patch on your quit day
  • If you smoke more than 10 cigarettes per day, use the following schedule below: 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 1-4 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
  • 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
  • It is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Warnings

SECTION 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. 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.
  • Stomach ulcer or diabetes.history of seizures. 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
  • 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.
  • You have symptoms of an allergic reaction (such as difficulty breathing or rash). 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.

Ask a doctor before use

  • 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.
  • Stomach ulcer or diabetes.history of seizures.

Ask a doctor or pharmacist before use

  • 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

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

Stop use and ask a doctor

  • 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.
  • You have symptoms of an allergic reaction (such as difficulty breathing or rash).

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.

Inactive ingredients

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

Questions?

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.

Forms and strengths

From the FDA NDC Directory · 2 product codes

Dosage formStrengthRouteNDCs
Patch, extended release14 mg/24htransdermal1
Patch, extended release21 mg/24htransdermal1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 40,213 reports that list nicotine, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Drug ineffective5,266
  • Nausea3,270
  • Application site erythema3,142
  • Application site pruritus3,069
  • Nicotine dependence2,751
  • Dizziness1,910
  • Headache1,645
  • Malaise1,636
  • Wrong technique in product usage process1,257
  • Vomiting1,255

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label · 1 from repackagers

    Repackager labels (1)
    • Chain Drug Marketing Association INC07/25/2024

    Related recalls

    FDA drug recalls that name this drug or its active ingredient

    All drug recalls

    Nicotine transdermal system step 2: common questions

    What is Nicotine transdermal system step 2 used for?
    reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
    Is Nicotine transdermal system step 2 a prescription drug?
    No. Nicotine transdermal system step 2 is sold over the counter (OTC) without a prescription.
    Are there other products with the same active ingredient as Nicotine transdermal system step 2?
    Yes. Other FDA-listed products with the same active ingredients include Nicotine, Nicotine Mini, Nicotine Polacrilex, Mini Nicotine.
    Who makes Nicotine transdermal system step 2?
    Chain Drug Marketing Association INC lists Nicotine transdermal system step 2 with the FDA.

    Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/25/2024 · Label text is shown as published by the manufacturer. Not medical advice