BOTASUN QUIT SMOKING NICOTINE- nicotine18% menthol 0.3% quit smoking nicotine patch

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Nicotine 18%.menthol 0.3%

Purpose

stop smoking aid

Use

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

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

Do not use

Do not wear more than one patch at a time.Do not cut patch in half or into smaller pieces.Do not leave patch on for more than 24 hours.because it may irritate your skin and loses strength after 24 hours.To avoid possible burns, remove patch before undergoing any MRl (magnetic resonance imaging)procedures.It is important to complete treatment,if you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

When Using

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

Stop Use

Stop use and ask a doctor if Feeling uncomfortable or experiencing or other sensitive dizziness symptoms

Ask Doctor

Ask a doctor before use if you have
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.
Ask a doctor or pharmacist before use if you are: Using a non-nicotine stop smoking drug.
Taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Keep Out Of Reach Of Children

Keep out ofreach of children and pets.

Directions

If you are under 18 years of age, ask adoctor before use.

Before using this product,need the enclosed self-help guide for complete directions and other information. Begin using the patch on your quit day.

If you smoke more than 10 cigarettes per day, use the following schedule below.

The used patch should be removed and a new one applied to a different skin site at the same time each day.

If you have vivid dreams, you may removethe patch at bedtime and apply a new one in the morning.

Do not wear more than one patch at a time.Do not cut patch in half or into smaller pieces.

Do not leave patch on for more than 24 hours.because it may irritate your skin and loses strength after 24 hours.To avoid possible burns, remove patch before undergoing any MRl (magnetic resonance imaging)procedures.

It is important to complete treatment,if you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Signs of excessive use may include nausea.vomiting,dizziness,weakness, or rapid heartbeat.lf these symptoms occur,remove the patch immediately and contact a doctor or poison control center

Other information

store at 20-25°C

Inactive ingredients

acrylate adhesive，cellulose paper，methacrylic acid .

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOTASUN QUIT SMOKING NICOTINE 
nicotine18% menthol 0.3% quit smoking nicotine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85248-189
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.3 g  in 100
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	18 g  in 100

Inactive Ingredients
Ingredient Name	Strength
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
METHACRYLIC ACID (UNII: 1CS02G8656)
2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85248-189-01	21 in 1 BOX; Type 0: Not a Combination Product	04/17/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/17/2026

Labeler - Jiangxi Yudexi Pharmaceutical Co., LTD (455662836)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.		411295811	manufacture(85248-189)