Quit Smoking Nicotine Patches

Manufacturer
Shenzhen Paxi Trading Co., Ltd.
Effective date
2025-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:00

Label at a glance#

ProductQuit Smoking Nicotine Patches
Active ingredientNICOTINE
Label structure14 sections

Dosage and administration

If you are under 18 years of age, ask a doctor before use. Before using this product, read the enclosed self–help guide for complete directions and other information. Begin using the patch on your quit day. If you smoke more than 20 cigarettes per day, use the following schedule below: Weeks 1 and 2 STEP 1+ use1½ patch/day Weeks 3 and 6 STEP 1 use 1 patch/day Weeks 7 and 8 STEP 2 use I/2 patch/day Weeks 9 and 10 S...

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Nicotine 28mg

Purpose

OTC - PURPOSE SECTION

Stopsmoking aid

Use

INDICATIONS & USAGE SECTION

Apply one new patch every 24 hours on skin that is dry, clean and hairless.
Wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.
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 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 MRI (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 healthcare provider.

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

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.

When Using

OTC - WHEN USING SECTION

When using this product
- if you have vivid dreams or other sleep disturbance are removed this patch at bedtime.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if
- skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash.
- irregular heartbeat or palpitations occur.
- you get symptoms of nicotine overdose, such as persistent nausea, vomiting, dizziness, weakness and rapid heartbeat.
- you have symptoms of an allergic reaction (such as difficulty breathing or rash).

Ask Doctor

OTC - ASK DOCTOR SECTION

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 of reach of children and pets
Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

Directions

DOSAGE & ADMINISTRATION SECTION

If you are under 18 years of age, ask a doctor before use.
Before using this product, read the enclosed self–help guide for complete directions and other information.
Begin using the patch on your quit day.
If you smoke more than 20 cigarettes per day, use the following schedule below:

Weeks 1 and 2
STEP 1+
use1½
patch/day

Weeks 3 and 6
STEP 1
use 1
patch/day

Weeks 7 and 8
STEP 2
use I/2
patch/day

Weeks 9 and 10
STEP 3
use I/4
patch/day

If you smoke more than 10 but not more than 20 cigarettes, start with Step 1, if you smoke 10 or less cigarettes per day, start with Step 2 for 4 weeks (Start with 1 patch or 3/4 patch for the first week), then on to Step 3 for 2 weeks. (Read the enclosed self–help guide for additional information.)
Apply one new patch every 24 hours on skin that is dry, clean and hairless.
Wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.
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 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 MRI (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 healthcare provider.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Questions

OTC - QUESTIONS SECTION

After-salesservice contactinformation.
lf you have any doubts with our products, please contact us.
Paxitrading@outlook.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2707585nicotine 28 MG/Day 24HR Transdermal PatchPSN1
270758524 HR nicotine 1.17 MG/HR Transdermal SystemSCD1
2707585nicotine 28 MG/Day 24 HR Transdermal PatchSY1

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
85835-001-01Quit Smoking Nicotine Patches15 in 1 BOXPATCH151
85835-001-02Quit Smoking Nicotine Patches30 in 1 BOXPATCH301

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
85835-00185835-001-01, 85835-001-02

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

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
Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.38c1616e-3b09-0669-e063-6294a90a2c862025-06-29WarningsExact identifier
ndc (package): 85835-001-02
ndc (package): 85835-001-01
ndc (product): 85835-001
ndc11 (package): 85835000102
ndc11 (package): 85835000101
spl id: 38c1616e-3b0a-0669-e063-6294a90a2c86
spl set id: 38c1616e-3b09-0669-e063-6294a90a2c86

Reported adverse events (FAERS/openFDA)#

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