85248-012

85248-012
SPL v1
SPL
SPL Set ID 495b10ce-3d2d-1aa4-e063-6294a90a4f35
Route
TOPICAL
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (18 g) Menthol (0.3 g)
Inactive Ingredients
2-hydroxyethyl Acrylate Methacrylic Acid Powdered Cellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-27

Description

Nicotine 18%.menthol 0.3%

Purpose

stop smoking aid


Medication Information

Purpose

stop smoking aid

Description

Nicotine 18%.menthol 0.3%

Use

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

Stop Use

Stop use and ask a doctor if Feeling uncomfortable or experiencing or other sensitive dizziness symptoms

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

Ask Doctor

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.

Directions

If you are under 18 years of age, ask adoctor before use. Before using this product,need 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. 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 removethe 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 MRl (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. Signs of excessive use may include nausea.vomiting,dizziness,weakness, or rapid heartbeat.lf these symptoms occur,remove the patch immediately and contact a doctor or poison control center

Do Not Use

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 MRl (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.

When Using

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

Active Ingredient

Nicotine 18%.menthol 0.3%

Other Information

store at 20-25°C

Inactive Ingredients

acrylate adhesive,cellulose paper,methacrylic acid .

Principal Display Panel

Keep Oot of Reach of Children

Keep out ofreach of children and pets.


Structured Label Content

Use

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

Purpose

stop smoking aid

Stop Use

Stop use and ask a doctor if Feeling uncomfortable or experiencing or other sensitive dizziness symptoms

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

Ask Doctor

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.

Directions

If you are under 18 years of age, ask adoctor before use. Before using this product,need 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. 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 removethe 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 MRl (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. Signs of excessive use may include nausea.vomiting,dizziness,weakness, or rapid heartbeat.lf these symptoms occur,remove the patch immediately and contact a doctor or poison control center

Do Not Use (Do not use)

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 MRl (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.

When Using

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

Active Ingredient

Nicotine 18%.menthol 0.3%

Other Information (Other information)

store at 20-25°C

Inactive Ingredients (Inactive ingredients)

acrylate adhesive,cellulose paper,methacrylic acid .

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out ofreach of children and pets.


Advanced Ingredient Data


Raw Label Data

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