85248-189update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-06-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-17 05:10:10

Label at a glance#

ProductBOTASUN QUIT SMOKING Nicotine
Active ingredientMENTHOL, NICOTINE
Label structure13 sections

Dosage and administration

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,...

Storage and handling

store at 20-25°C

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Nicotine 18%.menthol 0.3%

Purpose

OTC - PURPOSE SECTION

stop smoking aid

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

Stop Use

OTC - STOP USE SECTION

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

Ask Doctor

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out ofreach of children and pets.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store at 20-25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylate adhesive,cellulose paper,methacrylic acid .

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

18 0.318 0.3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843980128GTIN-13: 6979843980128
EAN-13: 6979843980128
GTIN storage (14 digits): 06979843980128
e1b308eb2b5a705a3199f744ef50ceb0.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-18985248-189-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-04-16full-release2026-06-01 01:54:08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BOTASUN QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD4fa00db9-def5-dcfa-e063-6394a90ac8c22026-06-14WarningsExact identifier
ndc (package): 85248-189-01
ndc (product): 85248-189
ndc11 (package): 85248018901
spl id: 5442a41b-0157-1562-e063-6394a90a48f3
spl set id: 4fa00db9-def5-dcfa-e063-6394a90ac8c2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.