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FDA Approval

FIobow QUIT SMOKING Nicotine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Jiangxi Hemei Pharmaceutical Co., Ltd
DUNS: 724892056
Effective Date
June 19, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Menthol(0.3 g in 100 1)
Nicotine(18 g in 100 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Jiangxi Hemei Pharmaceutical Co., Ltd

Jiangxi Hemei Pharmaceutical Co., Ltd

724892056

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

FIobow QUIT SMOKING Nicotine

Product Details

NDC Product Code
84010-137
Application Number
M017
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
June 19, 2025
MentholActive
Code: L7T10EIP3AClass: ACTIBQuantity: 0.3 g in 100 1
2-HYDROXYETHYL ACRYLATEInactive
Code: 25GT92NY0CClass: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9MClass: IACT
NicotineActive
Code: 6M3C89ZY6RClass: ACTIBQuantity: 18 g in 100 1
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

1


INDICATIONS & USAGE SECTION

Use

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

DOSAGE & ADMINISTRATION SECTION

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


WARNINGS SECTION

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


STORAGE AND HANDLING SECTION

Other information

store at 20-25°C


OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Nicotine 18%

menthol 0.3%

OTC - PURPOSE SECTION

Purpose

stop smoking aid

OTC - ASK DOCTOR SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of Children

Keep out ofreach of children and pets.

OTC - DO NOT USE SECTION

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.

OTC - STOP USE SECTION

Stop Use

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

OTC - WHEN USING SECTION

When Using

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


INACTIVE INGREDIENT SECTION

Inactive ingredients

acrylate adhesive,cellulose paper,methacrylic acid


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