Nicotine
Nicotine Transdermal System
a08022ff-e412-47f9-8132-318f55528c5c
HUMAN OTC DRUG LABEL
Jul 30, 2025
Strategic Sourcing Services LLC
DUNS: 116956644
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 (2)
Nicotine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Nicotine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON
Principal Display Panel - Step 3 – 7 mg Carton Label
McKesson SunMark ®
NDC 70677-0030-1
COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ®*
Clear
Nicotine
Transdermal System
7 mg delivered over 24 hours
STOP SMOKING AID
7 mg
Includes Behavior Support Program with Self-Help Guide
STEP ONE
If you smoke MORE than 10 cigarettes per day: Start with Step 1
If you smoke 10 or LESS cigarettes per day: Start with Step 2
14 Patches
*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.

INDICATIONS & USAGE SECTION
Uses
Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
OTC - PURPOSE SECTION
Purpose
Stop smoking aid
SPL UNCLASSIFIED SECTION
TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivated to quit.
2. Use one patch daily according to directions.
3. It is important to complete treatment.
4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.
5. Use patch with a behavioral support program such as the one described in the enclosed booklet.
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 smokemore than 10 cigarettes per day, use the following schedule below:
Weeks 1 thru 4 |
Weeks 5 and 6 |
Weeks 7 and 8 |
STEP 1 |
STEP 2 |
STEP 3 |
use one 21 mg patch/day |
use one 14 mg patch/day |
use one 7 mg patch/day |
- if you smoke10 or****less cigarettes per day,start withStep 2for 6 weeks, thenStep 3for 2 weeks
- apply one new patch every 24 hours on skin that is dry, clean, and hairless
- remove backing from patch and immediately press onto skin. Hold for 10 seconds.
- wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of used patch 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
- 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.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient Step Three (in each patch)
Nicotine, 7 mg delivered over 24 hours
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 skin problems because you are more likely to get rashes.
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
- do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.
- 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 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
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 used patch by folding sticky ends together and putting in pouch.
INACTIVE INGREDIENT SECTION
Inactive ingredients
acrylate adhesive, polyester, silicone adhesive