MedPath

Quit Smoking Nicotine Patches

85835-001

Approved
Approval ID

38c1616e-3b09-0669-e063-6294a90a2c86

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 29, 2025

Manufacturers
FDA

Shenzhen Paxi Trading Co., Ltd.

DUNS: 633886766

Products 1

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

Nicotine Transdermal Patches

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85835-001
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Nicotine Transdermal Patches
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 29, 2025
FDA Product Classification

INGREDIENTS (5)

NICOTINEActive
Quantity: 28 mg in 100 1
Code: 6M3C89ZY6R
Classification: ACTIB
ACRYLIC ACIDInactive
Code: J94PBK7X8S
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/30/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/30/2025

Use

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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/30/2025

Active Ingredient

Nicotine 28mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/30/2025

Purpose

Stopsmoking aid

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/30/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/30/2025

Questions

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

WARNINGS SECTION

LOINC: 34071-1Updated: 6/30/2025

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: 6/30/2025

Do not use

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.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/30/2025

When Using

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/30/2025

Stop Use

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).

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 6/30/2025

Ask Doctor

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

LOINC: 50565-1Updated: 6/30/2025

Keep Out Of Reach Of Children

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/30/2025

Directions

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/30/2025

Other information

Store at room temperature

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Quit Smoking Nicotine Patches - FDA Drug Approval Details