MedPath
FDA Approval

Nicotine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Target Corporation
DUNS: 006961700
Effective Date
June 10, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Nicotine(21 mg in 24 h)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Haleon US Holdings LLC

079944263

Products3

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

Nicotine transdermal system

Product Details

NDC Product Code
11673-194
Application Number
NDA020165
Marketing Category
NDA (C73594)
Route of Administration
TRANSDERMAL
Effective Date
June 10, 2025
NicotineActive
Code: 6M3C89ZY6RClass: ACTIBQuantity: 21 mg in 24 h
HIGH DENSITY POLYETHYLENEInactive
Code: UG00KM4WR7Class: IACT
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)Inactive
Code: L5F16ZG4ZUClass: IACT

Nicotine transdermal system

Product Details

NDC Product Code
11673-195
Application Number
NDA020165
Marketing Category
NDA (C73594)
Route of Administration
TRANSDERMAL
Effective Date
June 10, 2025
NicotineActive
Code: 6M3C89ZY6RClass: ACTIBQuantity: 14 mg in 24 h
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)Inactive
Code: L5F16ZG4ZUClass: IACT
HIGH DENSITY POLYETHYLENEInactive
Code: UG00KM4WR7Class: IACT

Nicotine transdermal system

Product Details

NDC Product Code
11673-196
Application Number
NDA020165
Marketing Category
NDA (C73594)
Route of Administration
TRANSDERMAL
Effective Date
June 10, 2025
NicotineActive
Code: 6M3C89ZY6RClass: ACTIBQuantity: 7 mg in 24 h
HIGH DENSITY POLYETHYLENEInactive
Code: UG00KM4WR7Class: IACT
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)Inactive
Code: L5F16ZG4ZUClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

Compare to the active ingredient in NicoDerm® CQ®*

Nicotine Patch

Nicotine Transdermal System 7 mg Delivered Over 24 Hours

Stop Smoking Aid

Step 3 7 mg

For useafter completing Step 2

up&up TM 14 CLEAR PATCHES (2-WEEK KIT)

NDC 11673-196-02

Up and Up Nicotine Patch 7 mg 14 ct


INDICATIONS & USAGE SECTION

Use

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

DOSAGE & ADMINISTRATION SECTION

Directions

**if you are under 18 years of age, ask a doctor before use**

before using this product, read the enclosed User’s 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 according to the following 10 week schedule:   

STEP 1

STEP 2

STEP 3

Use one 21mg patch/day

Use one 14mg patch/day

Use one 7mg patch/day

Weeks 1-6

Weeks 7-8

Weeks 9-10

if you smoke**10 or less cigarettes per day,**do not use** STEP 1 (21mg).**Start with**STEP 2 (14mg)** for 6 weeks, then**STEP 3 (7mg)** for 2 weeks and then stop.

steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.

apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.

remove backing from patch and immediately press onto skin. Hold for 10 seconds.

wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling. 

you may wear the patch for 16 or 24 hours.

if you crave cigarettes when you wake up, wear the patch for 24 hours.

if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning

the used patch should be removed and a new one applied to a different skin site at the same time each day

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

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 health care provider.

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.

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 ulcers 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 this patch at bedtime

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 nausea, vomiting, dizziness, weakness and rapid heartbeat

you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.


OTC - ACTIVE INGREDIENT SECTION

Active ingredient Step 3 (in each patch)

Nicotine, 7 mg delivered over 24 hours

OTC - PURPOSE SECTION

Purpose

Stop smoking aid

OTC - QUESTIONS SECTION

Questions or comments?

call toll-free1-888-367-7919


SPL UNCLASSIFIED SECTION

Generic Section

Read carton and enclosed user’s guide before using this product. Keep this carton and user’s guide. They contain important information.

*NICODERM and CQ are registered trademarks owned by and/or licensed to the GSK group of companies.

Includes user’s guide with behavioral support program enrollment offer.

To increase your success in quitting:

You must be motivated to quit.
Complete the full treatment program, applying a new patch every day.
Use with a support program as described in the enclosed user’s guide.

**not for sale to those under 18 years of age**

**proof of age required**

**not for sale in vending machines or from any source where proof of age cannot be verified**

For your family’s protection, nicotine patches are supplied in child resistant pouches. Do not use if individual pouch is open or torn.

What is the Nicotine Patch and how is it used?

The Nicotine Patch is a small, nicotine-containing patch. When you put on a Nicotine Patch, nicotine passes through the skin and into your body. The Nicotine Patch is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 16- or 24-hour period you wear the nicotine patch. This helps to reduce cravings you may have for nicotine.

READ THE LABEL

Satisfaction guaranteed – Love it or your money back.

Distributed by Target Corporation

Minneapolis, MN 55403

Made in Ireland

TM & © 2024 Target Brands, Inc.

INACTIVE INGREDIENT SECTION

Inactive ingredients

ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings


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