NICOTINE PATCH- nicotine patch

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

NICOTINE 7mg
NICOTINE 14mg
NICOTINE 21mg

PURPOSE

quit smoking

WARNINGS

If pregnant or breastfeeding, use only on advice of healthcare provider.
Smoking seriously harms your child. Try to quit without nicotine replacement if possible. This medicine is believed safer than smoking, but risks to your child are not fully known.

INDICATIONS & USAGE

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

DO NOT USE

If pregnant or breastfeeding, use only on advice of healthcare provider.
Smoking seriously harms your child. Try to quit without nicotine replacement if possible. This medicine is believed safer than smoking, but risks to your child are not fully known.

WHEN USING

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.

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.

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

STOP USE

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 nausea, vomiting, dizziness, weakness and rapid beartbeat.
you have symptoms of an allergic reaction (suchas difficulty breathing or rash).

KEEP OUT OF REACH OF CHILDREN

Used patches contain enough nicotine to poison children or pets. If swallowed, get medical help or contact Poison Control immediately. Dispose by folding sticky ends together and placing in pouch.

DOSAGE & ADMINISTRATION

If you are under 18 years of age, ask a doctor beforeuse

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 10 cigarettes per day, use the following schedule below

Weeks 1 thru 4 STEP 1:use one 21 mg patch/day

Weeks 5 and 6 STEP 2:use one 14 mg patch/day

Weeks 7 and 8 STEP 3:use one 7 mg patch/day

· If you smoke <10 cigarettes/day: start with Step 2 for 6 weeks, then Step 3 for 2 weeks.·

Under 18: ask a doctor before use.·

Apply one new patch every 24 hours to dry, clean,hairless skin.

Remove backing, press onto skin for 10 seconds.

Wash hands after handling. Dispose of used patches by folding sticky ends together and placing in original pouch.

Remove old patch and apply new one to a different skin site at the same time each day.

If vivid dreams occur, remove patch at bedtime and apply new one in the morning

Do not cut patch. Do not wear more than one patchat a time.·

Do not leave on longer than 24 hours (may irritateskin and loses strength).

Remove patch before MRI procedures to avoid burns.·

Complete treatment. If you need to use longer to stay smoke-free, talk to your healthcare provider.

INACTIVE INGREDIENT

Acrylate adhesive
Aluminized polyester
Cellulose paper
Methacrylic acid copolymer

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NICOTINE PATCH 
nicotine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87704-002
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	7 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
POLYESTER (ADIPIC ACID, 1,6-HEXANEDIOL, NEOPENTYL GLYCOL) (UNII: 571593769G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87704-002-01	30 in 1 BOX	05/20/2026
1		10 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	05/20/2026

NICOTINE PATCH 
nicotine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87704-003
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	14 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
POLYESTER (ADIPIC ACID, 1,6-HEXANEDIOL, NEOPENTYL GLYCOL) (UNII: 571593769G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87704-003-01	30 in 1 BOX	05/20/2026
1		1 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	05/20/2026

NICOTINE PATCH 
nicotine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87704-004
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	21 mg

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
POLYESTER (ADIPIC ACID, 1,6-HEXANEDIOL, NEOPENTYL GLYCOL) (UNII: 571593769G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87704-004-01	30 in 1 BOX	05/20/2026
1		1 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	05/20/2026

Labeler - Guangzhou Yunzhen Trading Co., Ltd. (451601414)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yunzhen Trading Co., Ltd.		451601414	manufacture(87704-002, 87704-003, 87704-004)