84318-001

84318-001
SPL v2
SPL
SPL Set ID 17745de2-83c1-3d62-e063-6294a90aa4ac
Route
TRANSDERMAL
Published
Effective Date 2024-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg)
Inactive Ingredients
Polypropylene (30000 Mw) Polyethylene Terephthalate (intrinsic Viscosity 0.40-0.70) Methacrylic Acid And Ethyl Acrylate Copolymer

Identifiers & Packaging

Marketing Status
NDA Active Since 2024-05-10

Description

Nicotine, 21 mg delivered over 24 hours.


Medication Information

Warnings and Precautions

If you are breast-feeding or pregnant,you should not use nicotine patches in any form asit may have adverse effects onyour baby's development. Try to stopsmoking without using any nicotine replacement medicine.This medicine is believed to be safer than smoking. However,the risks to your child from this medicine arenot fully known.

Indications and Usage

Reduces withdrawral symptoms, including nicotine craving.associated with quiting smoking.

Dosage and Administration

Directions

-If youare under 18 years of age,ask a doctor before use.

-Start using the patch on quit day.

-Because the different types of cigarettes that each person smokes, thenicotine content of each type of cigarette varies, and the amount absorbed by thehuman body also varies. Therefore, if you smoke 10 or fewer cigarettes per day,stick between 0.5and 1.5 patches each time. Ifyou smoke more than 10 cigarettes per day, stick between 1 and 5 patches each time. Before using this product, carefully read the product instructions inside the packaging for a complete list of usage quantities.

-Apply anewpatch to dry, dlean, hair-free skin every24 hours.

-Remove backing from patch and press immediately to skin.hold for 10 seconds.

-Wash your hands after applying or removing the patch.Save pouch to use for patch disposal.

- Dispose of used patches by folding them together and placing them in a bag.

-Used patches should be removed and new patches applied to a diflerent area of skin at the same time each day

- If you havevivid dreams, you may remove the patch at bedtime and apply a new one in themorning.

- Do not leave the patch on for more than 24 hours as it may irritate your skin and losestrength after 24 hours

-It is important to complete treatment and talk to your healthcare provider if you feel you need to use the patch longer to quit smoking.

Description

Nicotine, 21 mg delivered over 24 hours.

Section 44425-7

Store at 20-25℃(68-77°F)

Detailed product instructions included in the package

Section 50565-1

Keep out of reach of children and petsUsed patches contain enough nicotine to poison children and pets. If swallowed, get medical help or contact a poison control center immediately and save bag for patch disposal. Dispose of used patches by folding the sticky ends together and placing in a bag

Section 50566-9

Stop use and ask a doctor if

Aheart attack in the last two weeks.

A serious heart rhythm problem.

Pain in your heart (angina) that is serious or getting worse.

Alergy to adhesive tape or other serious skin problemslike psoriasis and eczema.

High blood pressure not controlled with medication.Nicotine can increaseblood pressure

Stomach ulcer or diabetes

Ahistory of seizures

Section 50567-7

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

Section 50570-1

Ask a doctor or pharmacist before use if you are

Use non-nicotine smoking cessation medications

Take prescription medications for depression or asthma.

Less than 18 years old.

Section 51727-6

acrylate copolymer,polypropylene,polyethylene terephthalate

Section 51945-4

Section 55105-1

Stop smoking aid

Section 55106-9

Nicotine, 21 mg delivered over 24 hours.


Structured Label Content

Indications and Usage (34067-9)

Reduces withdrawral symptoms, including nicotine craving.associated with quiting smoking.

Dosage and Administration (34068-7)

Directions

-If youare under 18 years of age,ask a doctor before use.

-Start using the patch on quit day.

-Because the different types of cigarettes that each person smokes, thenicotine content of each type of cigarette varies, and the amount absorbed by thehuman body also varies. Therefore, if you smoke 10 or fewer cigarettes per day,stick between 0.5and 1.5 patches each time. Ifyou smoke more than 10 cigarettes per day, stick between 1 and 5 patches each time. Before using this product, carefully read the product instructions inside the packaging for a complete list of usage quantities.

-Apply anewpatch to dry, dlean, hair-free skin every24 hours.

-Remove backing from patch and press immediately to skin.hold for 10 seconds.

-Wash your hands after applying or removing the patch.Save pouch to use for patch disposal.

- Dispose of used patches by folding them together and placing them in a bag.

-Used patches should be removed and new patches applied to a diflerent area of skin at the same time each day

- If you havevivid dreams, you may remove the patch at bedtime and apply a new one in themorning.

- Do not leave the patch on for more than 24 hours as it may irritate your skin and losestrength after 24 hours

-It is important to complete treatment and talk to your healthcare provider if you feel you need to use the patch longer to quit smoking.

Warnings and Precautions (34071-1)

If you are breast-feeding or pregnant,you should not use nicotine patches in any form asit may have adverse effects onyour baby's development. Try to stopsmoking without using any nicotine replacement medicine.This medicine is believed to be safer than smoking. However,the risks to your child from this medicine arenot fully known.

Section 44425-7 (44425-7)

Store at 20-25℃(68-77°F)

Detailed product instructions included in the package

Section 50565-1 (50565-1)

Keep out of reach of children and petsUsed patches contain enough nicotine to poison children and pets. If swallowed, get medical help or contact a poison control center immediately and save bag for patch disposal. Dispose of used patches by folding the sticky ends together and placing in a bag

Section 50566-9 (50566-9)

Stop use and ask a doctor if

Aheart attack in the last two weeks.

A serious heart rhythm problem.

Pain in your heart (angina) that is serious or getting worse.

Alergy to adhesive tape or other serious skin problemslike psoriasis and eczema.

High blood pressure not controlled with medication.Nicotine can increaseblood pressure

Stomach ulcer or diabetes

Ahistory of seizures

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Ask a doctor or pharmacist before use if you are

Use non-nicotine smoking cessation medications

Take prescription medications for depression or asthma.

Less than 18 years old.

Section 51727-6 (51727-6)

acrylate copolymer,polypropylene,polyethylene terephthalate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop smoking aid

Section 55106-9 (55106-9)

Nicotine, 21 mg delivered over 24 hours.


Advanced Ingredient Data


Raw Label Data

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