Nicotine
Drug Facts
f8d6bf61-6d66-4651-8145-c4cb1d5e443f
HUMAN OTC DRUG LABEL
Jun 10, 2025
Target Corporation
DUNS: 006961700
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nicotine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
nicotine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
nicotine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (3)
Drug Labeling Information
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
INDICATIONS & USAGE SECTION
Use
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
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
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.
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.
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
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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
OTC - QUESTIONS SECTION
Questions or comments?
call toll-free1-888-367-7919