318edb38-626c-241d-e063-6294a90a78dc

SPL v5
SPL
SPL Set ID 318edb38-626c-241d-e063-6294a90a78dc
Route
cutaneous
Published
Effective Date 2025-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
nicotine (1 U)
Inactive Ingredients
polyacrylate-13 butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) pegoterate powdered cellulose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-30

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.

Purpose

Usereduces withdrawal symptoms,includingassociated withnicotine craving,quitting smoking

Description

Nicotine


Medication Information

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.

Uses

Use reduces withdrawal symptoms,includingnicotine craving, associated withquitting smoking

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

Label

Stop Use

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

Active Ingredients

Nicotine

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

POLYACRYLATE-13, PEGOTERATE, POWDERED CELLULOSE, BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)

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

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.

Uses (USES)

Use reduces withdrawal symptoms,includingnicotine craving, associated withquitting smoking

Purpose

Usereduces withdrawal symptoms,includingassociated withnicotine craving,quitting smoking

Label (LABEL)

Stop Use (STOP USE)

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

Active Ingredients (Active ingredients)

Nicotine

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)

POLYACRYLATE-13, PEGOTERATE, POWDERED CELLULOSE, BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)

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

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