85835-016 V2 Add Pack 180patchs

85835-016 V2 Add Pack 180patchs
SPL v2
SPL
SPL Set ID 4582b4e9-0c24-069d-e063-6394a90a6f4b
Route
TOPICAL
Published
Effective Date 2026-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (3 mg)
Inactive Ingredients
Acrylic Acid Powdered Cellulose Polyester-7 Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-09

Description

Nicotine 3mg

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Nicotine 3mg

Use

Apply to dry, clean, hair-free skin.

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.

If vivid dreams occur, remove the patch before bedtime.

Do not cut patch in half or into smaller pieces

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.

Stop Use

- Patch-induced erythema persists beyond 4 days,localized edema develops, or a cutaneous rash appears.

- irregular heartbeat or palpitations occur.

- Symptoms of nicotine overdose may include 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 non-nicotine smoking cessation drug .

- are taking prescription medications for depression or asthma, your dosage may require adjustment.

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, follow the schedule below:

Weeks 1 and 4

STEP 1

1 patch every 1 to 2 hours

Weeks 5 and 7

STEP 2

1 patch every 2 to 4 hours

Weeks 8 and 10

STEP 3

use I/2

patch/day

Weeks 9 and 10

STEP 3

1 patch every 4 to 8 hours

to increase your chances of quitting, use at least 9 nicotine patches daily during the first week. If you experience strong or frequent cravings, you may apply a second patch within two hours. However, do not use one patch after another consecutively.

if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 3 weeks.

Apply to dry, clean, hair-free skin.

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.

If vivid dreams occur, remove the patch before bedtime.

Do not cut patch in half or into smaller pieces

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.

Do Not Use

Ask a doctor or pharmacist before use:

- Contraindicated in heart disease, recent MI, or arrhythmia. Nicotine may increase heart rate.

- History of seizures.

- Uncontrolled hypertension. Nicotine may elevate blood pressure.

- Stomach ulcer or diabetes .

- If allergic to adhesive or with pre-existing skin conditions, higher risk of dermal reactions may occur.

When Using

When using this product

- if you experience vivid dreams or other sleep disturbances, remove the patch at bedtime.

Active Ingredient

Nicotine 3mg

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

Apply to dry, clean, hair-free skin.

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.

If vivid dreams occur, remove the patch before bedtime.

Do not cut patch in half or into smaller pieces

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.

Purpose

Stop smoking aid

Stop Use

- Patch-induced erythema persists beyond 4 days,localized edema develops, or a cutaneous rash appears.

- irregular heartbeat or palpitations occur.

- Symptoms of nicotine overdose may include 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 non-nicotine smoking cessation drug .

- are taking prescription medications for depression or asthma, your dosage may require adjustment.

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, follow the schedule below:

Weeks 1 and 4

STEP 1

1 patch every 1 to 2 hours

Weeks 5 and 7

STEP 2

1 patch every 2 to 4 hours

Weeks 8 and 10

STEP 3

use I/2

patch/day

Weeks 9 and 10

STEP 3

1 patch every 4 to 8 hours

to increase your chances of quitting, use at least 9 nicotine patches daily during the first week. If you experience strong or frequent cravings, you may apply a second patch within two hours. However, do not use one patch after another consecutively.

if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 3 weeks.

Apply to dry, clean, hair-free skin.

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.

If vivid dreams occur, remove the patch before bedtime.

Do not cut patch in half or into smaller pieces

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.

Do Not Use (Do not use)

Ask a doctor or pharmacist before use:

- Contraindicated in heart disease, recent MI, or arrhythmia. Nicotine may increase heart rate.

- History of seizures.

- Uncontrolled hypertension. Nicotine may elevate blood pressure.

- Stomach ulcer or diabetes .

- If allergic to adhesive or with pre-existing skin conditions, higher risk of dermal reactions may occur.

When Using

When using this product

- if you experience vivid dreams or other sleep disturbances, remove the patch at bedtime.

Active Ingredient

Nicotine 3mg

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.


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