SPL v1
SPL
SPL Set ID 3f3b2b65-8458-fa2b-e063-6394a90ad03b
Route
TOPICAL
Published
Effective Date 2025-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (28 mg)
Inactive Ingredients
Silicon Dioxide Lactase

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-10

Description

Nicotine,28mg delivered over 24 hours.....Stop Smoking Aid

Purpose

Usereduces withdrawal symptoms,includingassociated withnicotine craving,quitting smoking

Dosage and Administration

Heart disease, recent heart attack, or irregualrheartbeat, Nicotine can increase your heart rateHigh blood pressure not controlled withmedication, Nicotine can increase your bloodpressure.An allergy to adhesive tape or have skin problems.because you are more likely to get rashes.Stomach ulcer or diabetes.History of seizures.


Medication Information

Purpose

Usereduces withdrawal symptoms,includingassociated withnicotine craving,quitting smoking

Dosage and Administration

Heart disease, recent heart attack, or irregualrheartbeat, Nicotine can increase your heart rateHigh blood pressure not controlled withmedication, Nicotine can increase your bloodpressure.An allergy to adhesive tape or have skin problems.because you are more likely to get rashes.Stomach ulcer or diabetes.History of seizures.

Description

Nicotine,28mg delivered over 24 hours.....Stop Smoking Aid

Uses

Use reduces withdrawal symptoms,includingnicotine craving, associated withquitting smoking

Label

Stop Use

Stop use and ask a doctor if Feelinguncomfortable or experiencingother sensitive dizziness symptoms

Warnings

If you are pregnant or breast-feeding, only use thismedicine on the advice of your health care provider.Smoking can seriously harm your child. Try to stopsmoking without using any nicotine replacementmedicine,This medicine is believed to be safer thansmoking.However, the risks to your child from thismedicine are not fully known.

Active Ingredients

Nicotine,28mg delivered over 24 hours.....Stop Smoking Aid

Do Not Use Section

Using a non-nicotine stop smoking rugTaking a prescription medicine for depressionor asthma. Your prescription dose may needto be adjusted.

When Using Section

Using a non-nicotine stop smoking rugTaking a prescription medicine for depressionor asthma. Your prescription dose may needto be adjusted. to maintain skin health, especially in winter or if you have skin sensitivity.

Inactive Ingredient

Colloidal Silicon Dioxide,Lactose,Polyester Film

Keep Out of Reach of Children.

Keep out of reach of childrenand pets.

Dosage and Administration Section

Heart disease, recent heart attack, or irregualrheartbeat, Nicotine can increase your heart rateHigh blood pressure not controlled withmedication, Nicotine can increase your bloodpressure.An allergy to adhesive tape or have skin problems.because you are more likely to get rashes.Stomach ulcer or diabetes.History of seizures.


Structured Label Content

Uses (USES)

Use reduces withdrawal symptoms,includingnicotine craving, associated withquitting smoking

Label (LABEL)

Purpose

Usereduces withdrawal symptoms,includingassociated withnicotine craving,quitting smoking

Stop Use (STOP USE)

Stop use and ask a doctor if Feelinguncomfortable or experiencingother sensitive dizziness symptoms

Warnings (WARNINGS)

If you are pregnant or breast-feeding, only use thismedicine on the advice of your health care provider.Smoking can seriously harm your child. Try to stopsmoking without using any nicotine replacementmedicine,This medicine is believed to be safer thansmoking.However, the risks to your child from thismedicine are not fully known.

Active Ingredients (Active ingredients)

Nicotine,28mg delivered over 24 hours.....Stop Smoking Aid

Do Not Use Section (DO NOT USE SECTION)

Using a non-nicotine stop smoking rugTaking a prescription medicine for depressionor asthma. Your prescription dose may needto be adjusted.

When Using Section (WHEN USING SECTION)

Using a non-nicotine stop smoking rugTaking a prescription medicine for depressionor asthma. Your prescription dose may needto be adjusted. to maintain skin health, especially in winter or if you have skin sensitivity.

Inactive Ingredient (INACTIVE INGREDIENT)

Colloidal Silicon Dioxide,Lactose,Polyester Film

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

Keep out of reach of childrenand pets.

Dosage and Administration Section (DOSAGE AND ADMINISTRATION SECTION)

Heart disease, recent heart attack, or irregualrheartbeat, Nicotine can increase your heart rateHigh blood pressure not controlled withmedication, Nicotine can increase your bloodpressure.An allergy to adhesive tape or have skin problems.because you are more likely to get rashes.Stomach ulcer or diabetes.History of seizures.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)