84288-007 Nwrb Nicotine Transdermal Patch

84288-007 Nwrb Nicotine Transdermal Patch
SPL v1
SPL
SPL Set ID 44f3e697-1859-dab0-e063-6294a90a4517
Route
TRANSDERMAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg)
Inactive Ingredients
Lauryl Alcohol Polyethylene Terephthalate (intrinsic Viscosity 0.60-0.70) Polyacrylate-13

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-02

Description

Nicotine 21mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

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

Dosage and Administration



lf you are under 18 years of age, ask a doctor before use.

Before using this product, read the enclosed User's Guide for complete directions and other information.

Use 1 patch every 24 hours. Apply to a clean, dry,hairless area of skin on the upper arm, hip, or torso.

Begin using the patch on your quit day, use according to the following 8-week schedule.

Description

Nicotine 21mg

Section 50565-1

Used patches have enough nicotine to poison children and pets. lf 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.

Section 50566-9



Skin redness caused by the patch does not go away after four days, or if your skin swells,or you get a rash.

lrregular 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).

Section 50567-7

If you have vivid dreams or other sleep disturbances,remove the patch at bedtime.

Section 50570-1



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

Section 51727-6

Polyacrylate-13

Polyester Film

Lauryl Alcohol

Section 51945-4

Section 55105-1

Stop smoking aid

Section 55106-9

Nicotine 21mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)



lf you are under 18 years of age, ask a doctor before use.

Before using this product, read the enclosed User's Guide for complete directions and other information.

Use 1 patch every 24 hours. Apply to a clean, dry,hairless area of skin on the upper arm, hip, or torso.

Begin using the patch on your quit day, use according to the following 8-week schedule.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Used patches have enough nicotine to poison children and pets. lf 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.

Section 50566-9 (50566-9)



Skin redness caused by the patch does not go away after four days, or if your skin swells,or you get a rash.

lrregular 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).

Section 50567-7 (50567-7)

If you have vivid dreams or other sleep disturbances,remove the patch at bedtime.

Section 50570-1 (50570-1)



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

Section 51727-6 (51727-6)

Polyacrylate-13

Polyester Film

Lauryl Alcohol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop smoking aid

Section 55106-9 (55106-9)

Nicotine 21mg


Advanced Ingredient Data


Raw Label Data

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