MedPath

Rstrvbr QUIT SMOKING

84010-185

Approved
Approval ID

3f247bed-0263-495b-e063-6294a90aefaa

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Jiangxi Hemei Pharmaceutical Co., Ltd

DUNS: 724892056

Products 1

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

Nicotine7mg QUIT SMOKING

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84010-185
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Nicotine7mg QUIT SMOKING
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (3)

NICOTINEActive
Quantity: 7 mg in 100 1
Code: 6M3C89ZY6R
Classification: ACTIB
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

PRINCIPAL DISPLAY PANEL

7

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2025

Use

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/19/2025

Active Ingredient

Nicotine,7mg delivered over 24 hours

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/19/2025

Purpose

stop smoking aid

WARNINGS SECTION

LOINC: 34071-1Updated: 9/19/2025

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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/19/2025

Do not use

If you are allergic to any of the ingredients. ·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.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/19/2025

When Using

If you have vivid dreams or other sleep disturbances remov this patch at bedtime.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/19/2025

Stop Use

If Feeling uncomfortable or experiencing or other sensitive dizziness symptoms

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/19/2025

Ask Doctor

Heart disease, recent heart attack, or irrepular heartbeat. Nicotine canincrease your heart 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 Using a non-nicotine stop smokindrug.Taking a prescription medicine for depression or asthma Your prescription dose may need to be adjusted

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/19/2025

Keep Oot Of Reach Of Children

Keep out of reach of children and pets

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2025

Directions

lf you are under 18 years of age, ask a doctor before uSe, Beore using this product, need the enclosed self-help guidefor complete directions and other information.Bepin using the patch on your quit day. lf 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 remove the patch at bedtime and apply a new one in the morninp.Do not wear more than one patch at a time.Dnot cut patch in half or into smaller pieces.Do not leave patch on for more than 24 hours. Because it may irritate your skinand loses strength after 24 hours.To avoid possible bums,remove patch before undergoing any MRl (magnetic resonance imaging)procedures.
It is important to complete treatrent, 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 nauseavomiting,dizzines,weakness, or rapidheartbeat. lf these Symptoms occur, remove the patch immediately and contata doctor or poison control center.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/19/2025

Other information

store at 20-25℃ lnactive

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/19/2025

Inactive ingredients

acrylate adhesive,cellulose paper,methacrylic acid .

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Rstrvbr QUIT SMOKING - FDA Drug Approval Details