RBUGR QUIT SMOKING Nicotine Patches

Manufacturer
Nanjing Ludejin Corporation Management Co., Ltd
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:39:08

Label at a glance#

ProductRBUGR QUIT SMOKING Nicotine Patches
Active ingredientMENTHOL, NICOTINE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Nicotine18%
menthol 0.3%

OTC - PURPOSE SECTION

Stop smoking aid

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - WHEN USING SECTION


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.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION


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.

INACTIVE INGREDIENT SECTION

acrylate adhesive,cellulose paper, methacrylic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87165-001-01RBUGR QUIT SMOKING Nicotine Patches21 in 1 BOXPATCH211
87165-001-01RBUGR QUIT SMOKING Nicotine Patches1 in 1 PATCHPATCH11
87165-001-02RBUGR QUIT SMOKING Nicotine Patches42 in 1 BOXPATCH421
87165-001-02RBUGR QUIT SMOKING Nicotine Patches1 in 1 PATCHPATCH11
87165-001-03RBUGR QUIT SMOKING Nicotine Patches60 in 1 BOXPATCH601
87165-001-03RBUGR QUIT SMOKING Nicotine Patches1 in 1 PATCHPATCH11

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87165-00187165-001-01, 87165-001-02, 87165-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
NICOTINE6M3C89ZY6RACTIB
METHACRYLIC ACID1CS02G8656IACT

Source Document#

Source XML

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
RBUGR QUIT SMOKING Nicotine PatchesNICOTINENanjing Ludejin Corporation Management Co., Ltd412d42c7-d382-20cc-e063-6294a90ae3842025-10-15WarningsExact identifier
ndc (package): 87165-001-03
ndc (package): 87165-001-02
ndc (package): 87165-001-01
ndc (product): 87165-001
ndc11 (package): 87165000101
ndc11 (package): 87165000103
ndc11 (package): 87165000102
spl id: 412d42c7-d383-20cc-e063-6294a90ae384
spl set id: 412d42c7-d382-20cc-e063-6294a90ae384

Reported adverse events (FAERS/openFDA)#

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