87165-001 Rbugr Quit Smoking Nicotine Patches

87165-001 Rbugr Quit Smoking Nicotine Patches
SPL v1
SPL
SPL Set ID 412d42c7-d382-20cc-e063-6294a90ae384
Route
TOPICAL
Published
Effective Date 2025-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.003 g) Nicotine (0.18 g)
Inactive Ingredients
Methacrylic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-15

Description

Nicotine18% menthol 0.3%


Medication Information

Warnings and Precautions

If you are pregnant or breast-feeding, only use this patch on the advice of your health care provider.Smokina can seriously harm vour child. Try to stop smoking without using any nicotine replacement patch. This product is considered safer than smoking. However, the risks to your child from this patch are not fully known. The patch is effective in helping to alleviate nicotine cravings. lt is a health supplement to assist in quitting smoking and is not to be used in place of a nicotine patch.

Indications and Usage

USE reduces withdrawal symptoms,including nicotine craving, associated with quitting smoking.

Dosage and Administration



DIRECTIONS

If you are under 18 years of age, ask a doctor before use. e Before using this product, read the enclosed self-help guide for complete directions and other information. Begin using the patch on your quit day. o lf you smoke more than 10 cigarettes per day, use the following schedule below.

lf you smoke no more than ten cigarettes aday, please start with step 2. Keep your skinclean and dry before each use. lmmediatelyafter removing the adhesive backing, applythe patch to the skin and press the patchagainst the skin for ten seconds to ensure asnug fit. Wash your hands after each patchapplication and after removing the patchprivately.

Description

Nicotine18% menthol 0.3%

Section 50565-1

Please store in a cool dry place for best results. (preferably under 20-25°). Keep out of reach ofchildren and pets, Please wrap used patches completely before throwing them away. lf inadvertentlylicked by children or pets, get medical help or contact a Poison Control Center right away.

Section 50566-9

you are using a non-nicotine stop smoking drug. Taking a prescription medicine for depression orasthma, your prescription dose may need to be adiusted. o Skin redness caused by the patch does notgo away after 4 days. You develop a rash, swelling, or severe skin irritation. You experienceirreqular heartbeat or palpitations.o Symptoms of nicotine overdose occur (such as nausea, vomitingdizziness, or weakness). lt is important to complete treatment, if you feel you need to use the patchfor a longer period to keep from smoking, talk to your health care provider.

Section 50567-7



ASK A DOCTOR BEFORE USE IF YOU HAVE

Heart disease,recent heart attack, or irregular heartbeat. , Cardiovascular disorders History ofmyocardial infarction Documented arrhythmias High blood pressure not controlled by medication Stomach ulcer or diabetes Been prescribed medication for depression or asthma Non-tobaccousers or people with skin allergies.

WHEN USING THE PATCH

if you have vivid dreams or other sleep disturbances, remove this patch at bedtime. e Stop use and aska doctor if feeling uncomfortable or experiencing other sensitive dizziness symptoms. o And followphase recommendations (being adjusted within the recommended range according to your conditionand acceptability). o Do not cut the 7mg patch into halves or smaller pieces. To avoid possible burns.remove the patch before performing an MRl (Magnetic Resonance lmaging) examination. Adjust thewearing time according to your body weight and your smoking needs it is best to wear the patch formore than 12 hours in order to allow the nicotine in the patch to penetrate completely into the skin, andif you feel uncomfortable, you can use the intermittent patch method, i.e., temporarily remove the patchand put it back on once the discomfort subsides). e The used patch should be removed and a new oneapplied to a different skin site at the same time each day. Slight dizziness and nausea during use arenormal, please stop using temporarily and drink more water. Reduce the dosage and use it aaainwhen it returns to norma. it is important to complete treatment, if you feel you need to use the patchfor a longer period to keep from smoking, talk to your health care provider. lt is best to remove hairfrom the surface of the skin and keep the skin dry before use for best results. o Drink plenty of waterduring use of the patch to promote absorption and metabolism.

Section 50570-1

If you are allergic to any of the ingredients. e Gastric ulcers or diabetes mellitus, history of seizures prohibited. lf you are under 18 years of age without a doctor's recommendation. Do not use on damaged skin or wounds.

Section 51727-6

acrylate adhesive,cellulose paper, methacrylic acid

Section 51945-4

Section 55105-1

Stop smoking aid

Section 55106-9

Nicotine18%

menthol 0.3%


Structured Label Content

Indications and Usage (34067-9)

USE reduces withdrawal symptoms,including nicotine craving, associated with quitting smoking.

Dosage and Administration (34068-7)



DIRECTIONS

If you are under 18 years of age, ask a doctor before use. e Before using this product, read the enclosed self-help guide for complete directions and other information. Begin using the patch on your quit day. o lf you smoke more than 10 cigarettes per day, use the following schedule below.

lf you smoke no more than ten cigarettes aday, please start with step 2. Keep your skinclean and dry before each use. lmmediatelyafter removing the adhesive backing, applythe patch to the skin and press the patchagainst the skin for ten seconds to ensure asnug fit. Wash your hands after each patchapplication and after removing the patchprivately.

Warnings and Precautions (34071-1)

If you are pregnant or breast-feeding, only use this patch on the advice of your health care provider.Smokina can seriously harm vour child. Try to stop smoking without using any nicotine replacement patch. This product is considered safer than smoking. However, the risks to your child from this patch are not fully known. The patch is effective in helping to alleviate nicotine cravings. lt is a health supplement to assist in quitting smoking and is not to be used in place of a nicotine patch.

Section 50565-1 (50565-1)

Please store in a cool dry place for best results. (preferably under 20-25°). Keep out of reach ofchildren and pets, Please wrap used patches completely before throwing them away. lf inadvertentlylicked by children or pets, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

you are using a non-nicotine stop smoking drug. Taking a prescription medicine for depression orasthma, your prescription dose may need to be adiusted. o Skin redness caused by the patch does notgo away after 4 days. You develop a rash, swelling, or severe skin irritation. You experienceirreqular heartbeat or palpitations.o Symptoms of nicotine overdose occur (such as nausea, vomitingdizziness, or weakness). lt is important to complete treatment, if you feel you need to use the patchfor a longer period to keep from smoking, talk to your health care provider.

Section 50567-7 (50567-7)



ASK A DOCTOR BEFORE USE IF YOU HAVE

Heart disease,recent heart attack, or irregular heartbeat. , Cardiovascular disorders History ofmyocardial infarction Documented arrhythmias High blood pressure not controlled by medication Stomach ulcer or diabetes Been prescribed medication for depression or asthma Non-tobaccousers or people with skin allergies.

WHEN USING THE PATCH

if you have vivid dreams or other sleep disturbances, remove this patch at bedtime. e Stop use and aska doctor if feeling uncomfortable or experiencing other sensitive dizziness symptoms. o And followphase recommendations (being adjusted within the recommended range according to your conditionand acceptability). o Do not cut the 7mg patch into halves or smaller pieces. To avoid possible burns.remove the patch before performing an MRl (Magnetic Resonance lmaging) examination. Adjust thewearing time according to your body weight and your smoking needs it is best to wear the patch formore than 12 hours in order to allow the nicotine in the patch to penetrate completely into the skin, andif you feel uncomfortable, you can use the intermittent patch method, i.e., temporarily remove the patchand put it back on once the discomfort subsides). e The used patch should be removed and a new oneapplied to a different skin site at the same time each day. Slight dizziness and nausea during use arenormal, please stop using temporarily and drink more water. Reduce the dosage and use it aaainwhen it returns to norma. it is important to complete treatment, if you feel you need to use the patchfor a longer period to keep from smoking, talk to your health care provider. lt is best to remove hairfrom the surface of the skin and keep the skin dry before use for best results. o Drink plenty of waterduring use of the patch to promote absorption and metabolism.

Section 50570-1 (50570-1)

If you are allergic to any of the ingredients. e Gastric ulcers or diabetes mellitus, history of seizures prohibited. lf you are under 18 years of age without a doctor's recommendation. Do not use on damaged skin or wounds.

Section 51727-6 (51727-6)

acrylate adhesive,cellulose paper, methacrylic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Stop smoking aid

Section 55106-9 (55106-9)

Nicotine18%

menthol 0.3%


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