NiEnjoy Nicotine Transdermal System

Manufacturer
Hangzhou Fanhuo Network Technology Co., Ltd.
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:12:31

Label at a glance#

ProductNiEnjoy Nicotine Transdermal System
Active ingredientNICOTINE
Label structure12 sections

Storage and handling

Store at 20-25℃(68-77°F) Detailed product instructions included in the package

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 21 mg delivered over 24 hours.

OTC - PURPOSE SECTION

Stop smoking aid

INDICATIONS & USAGE SECTION

Reduces withdrawral symptoms, including nicotine craving.associated with quiting smoking.

WARNINGS SECTION

If you are breast-feeding or pregnant,you should not use nicotine patches in any form asit may have adverse effects onyour baby's development. Try to stopsmoking without using any nicotine replacement medicine.This medicine is believed to be safer than smoking. However,the risks to your child from this medicine arenot fully known.

OTC - DO NOT USE SECTION

Ask a doctor or pharmacist before use if you are

Use non-nicotine smoking cessation medications

Take prescription medications for depression or asthma.

Less than 18 years old.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

Aheart attack in the last two weeks.

A serious heart rhythm problem.

Pain in your heart (angina) that is serious or getting worse.

Alergy to adhesive tape or other serious skin problemslike psoriasis and eczema.

High blood pressure not controlled with medication.Nicotine can increaseblood pressure

Stomach ulcer or diabetes

Ahistory of seizures

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and petsUsed patches contain enough nicotine to poison children and pets. If swallowed, get medical help or contact a poison control center immediately and save bag for patch disposal. Dispose of used patches by folding the sticky ends together and placing in a bag

DOSAGE & ADMINISTRATION SECTION

Directions

-If youare under 18 years of age,ask a doctor before use.

-Start using the patch on quit day.

-Because the different types of cigarettes that each person smokes, thenicotine content of each type of cigarette varies, and the amount absorbed by thehuman body also varies. Therefore, if you smoke 10 or fewer cigarettes per day,stick between 0.5and 1.5 patches each time. Ifyou smoke more than 10 cigarettes per day, stick between 1 and 5 patches each time. Before using this product, carefully read the product instructions inside the packaging for a complete list of usage quantities.

-Apply anewpatch to dry, dlean, hair-free skin every24 hours.

-Remove backing from patch and press immediately to skin.hold for 10 seconds.

-Wash your hands after applying or removing the patch.Save pouch to use for patch disposal.

- Dispose of used patches by folding them together and placing them in a bag.

-Used patches should be removed and new patches applied to a diflerent area of skin at the same time each day

- If you havevivid dreams, you may remove the patch at bedtime and apply a new one in themorning.

- Do not leave the patch on for more than 24 hours as it may irritate your skin and losestrength after 24 hours

-It is important to complete treatment and talk to your healthcare provider if you feel you need to use the patch longer to quit smoking.

STORAGE AND HANDLING SECTION

Store at 20-25℃(68-77°F)

Detailed product instructions included in the package

INACTIVE INGREDIENT SECTION

acrylate copolymer,polypropylene,polyethylene terephthalate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

84318-001-0184318-001-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN2
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD2
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY2
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY2
198030nicotine 21 MG/Day 24HR Transdermal SystemSY2

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
84318-001-01NiEnjoy Nicotine Transdermal System7 in 1 BOXPATCH72
84318-001-01NiEnjoy Nicotine Transdermal System24 h in 1 PATCHPATCH242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84318-001NIENJOY NICOTINE TRANSDERMAL SYSTEM (NIENJOY NICOTINE TRANSDERMAL SYSTEM PATCH) PATCH [HANGZHOU FANHUO NETWORK TECHNOLOGY CO., LTD.]22 package rows20240516_17745de2-83c1-3d62-e063-6294a90aa4ac.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84318-00184318-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
187c3b07-77db-21bc-e063-6294a90afc1e17745de2-83c1-3d62-e063-6294a90aa4ac2024-05-15WarningsExact identifier
spl id: 187c3b07-77db-21bc-e063-6294a90afc1e
spl set id: 17745de2-83c1-3d62-e063-6294a90aa4ac

Reported adverse events (FAERS/openFDA)#

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