85835-006

85835-006
SPL v1
SPL
SPL Set ID 41422d04-160b-51b2-e063-6294a90ab2b2
Route
TOPICAL
Published
Effective Date 2025-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (7 mg)
Inactive Ingredients
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Acrylic Acid Polyester-7 Powdered Cellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-15

Description

Nicotine 7mg

Purpose

Stopsmoking aid


Medication Information

Purpose

Stopsmoking aid

Description

Nicotine 7mg

Use

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

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 healthcare provider.

Stop Use

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 persistent nausea, vomiting, dizziness, weakness and rapid heartbeat.

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

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.

Questions

After-sales service contact information:

For any product inquiries, contact us: [email protected]

Ask Doctor

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 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 20 cigarettes per day, use the following schedule below:

Weeks 1 and 2

STEP 1+

use1½

patch/day

Weeks 3 and 6

STEP 1

use 1

patch/day

Weeks 7 and 8

STEP 2

use I/2

patch/day

Weeks 9 and 10

STEP 3

use I/4

patch/day

If you smoke more than 10 but not more than 20 cigarettes, start with Step 1, if you smoke 10 or less cigarettes per day, start with Step 2 for 4 weeks (Start with 1 patch or 3/4 patch for the first week), then on to Step 3 for 2 weeks. (Read the enclosed self–help guide for additional information.)

Apply one new patch every 24 hours on skin that is dry, clean and hairless.

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 healthcare provider.

Do Not Use

Ask a doctor before use if you have

- heat 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.

When Using

When using this product

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

Active Ingredient

Nicotine 7mg

Other Information

Store at room temperature

Inactive Ingredients

acrylate adhesive, aluminized polyester,cellulose paper, methacrylic acid copolymer.

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children and pets

Used patches contain enough nicotine to poison children and pets. If swallowed, seek medical help immediately or contact a Poison Control Center 1-800-222-1222 right away. Save the pouch for patch disposal. Dispose of used patches by folding the sticky ends together and placing them in the pouch.


Structured Label Content

Use

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

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 healthcare provider.

Purpose

Stopsmoking aid

Stop Use

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 persistent nausea, vomiting, dizziness, weakness and rapid heartbeat.

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

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.

Questions

After-sales service contact information:

For any product inquiries, contact us: [email protected]

Ask Doctor

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 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 20 cigarettes per day, use the following schedule below:

Weeks 1 and 2

STEP 1+

use1½

patch/day

Weeks 3 and 6

STEP 1

use 1

patch/day

Weeks 7 and 8

STEP 2

use I/2

patch/day

Weeks 9 and 10

STEP 3

use I/4

patch/day

If you smoke more than 10 but not more than 20 cigarettes, start with Step 1, if you smoke 10 or less cigarettes per day, start with Step 2 for 4 weeks (Start with 1 patch or 3/4 patch for the first week), then on to Step 3 for 2 weeks. (Read the enclosed self–help guide for additional information.)

Apply one new patch every 24 hours on skin that is dry, clean and hairless.

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 healthcare provider.

Do Not Use (Do not use)

Ask a doctor before use if you have

- heat 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.

When Using

When using this product

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

Active Ingredient

Nicotine 7mg

Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

acrylate adhesive, aluminized polyester,cellulose paper, methacrylic acid copolymer.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children and pets

Used patches contain enough nicotine to poison children and pets. If swallowed, seek medical help immediately or contact a Poison Control Center 1-800-222-1222 right away. Save the pouch for patch disposal. Dispose of used patches by folding the sticky ends together and placing them in the pouch.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)