Quit Smoking Nicotine Patches
85835-001
38c1616e-3b09-0669-e063-6294a90a2c86
HUMAN OTC DRUG LABEL
Jun 29, 2025
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
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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
Active Ingredient
Nicotine 28mg
OTC - PURPOSE SECTION
Purpose
Stopsmoking aid
INACTIVE INGREDIENT SECTION
Inactive ingredients
Acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer
OTC - QUESTIONS SECTION
Questions
After-salesservice contactinformation.
lf you have any doubts with our products, please contact us.
Paxitrading@outlook.com
WARNINGS SECTION
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
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
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
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
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
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
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
Other information
Store at room temperature