Nicotine

Manufacturer: Praxis, LLC
Effective date: 2023-01-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 20:39:27

Label at a glance#

ProductNicotine

Active ingredientNICOTINE

Label structure15 sections

Indications and uses

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

Dosage and administration

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 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 m...

Contacts and useful links#

PhoneLabel contact1-844-562-7963

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient Step One (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 21 mg delivered over 24 hours

Active ingredient Step Two (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 14 mg delivered over 24 hours

Active ingredient Step Three (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 7 mg delivered over 24 hours

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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 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 smoke 10 or less cigarettes per day,start with Step 2for 6 weeks, then Step 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.

Other information

SPL UNCLASSIFIED SECTION

Store at 20°C-25°C (68°F-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylate adhesive, polyester, silicone adhesive

Comments or questions?

SPL UNCLASSIFIED SECTION

1-844-562-7963

TO INCREASE YOUR SUCCESS IN QUITTING:

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - Step 1 – 21 mg Carton Label

McKesson SunMark ^®

NDC 70677-0032-1

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ^®*

Clear

Nicotine

Transdermal System

21 mg delivered over 24 hours

STOP SMOKING AID

21 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.

nicotine-transdermal-system-one-carton.jpg

PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - Step 2 – 14 mg Carton Label

McKesson SunMark ^®

NDC 70677-0031-1

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ^®*

Clear

Nicotine

Transdermal System

14 mg delivered over 24 hours

STOP SMOKING AID

14 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.

nicotine-transdermal-system-two-carton.jpg

PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

nicotine-transdermal-system-three-carton.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59368-369	NICOTINE PATCH [PRAXIS, LLC]	1	Unmatched	20250427_339d8f89-3640-b7ca-e063-6394a90a6052.zip
59368-370	NICOTINE PATCH [PRAXIS, LLC]	1	Unmatched	20250427_339d8f89-3640-b7ca-e063-6394a90a6052.zip
59368-371	NICOTINE PATCH [PRAXIS, LLC]	1	Unmatched	20250427_339d8f89-3640-b7ca-e063-6394a90a6052.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Nicotine
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59368-369	59368-369-01
59368-370	59368-370-01
59368-371	59368-371-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	IACT
NICOTINE	6M3C89ZY6R	ACTIB
DIMETHICONE	92RU3N3Y1O	IACT
NICOTINE	6M3C89ZY6R	ACTIB
DIMETHICONE	92RU3N3Y1O	IACT
NICOTINE	6M3C89ZY6R	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
339d9469-f095-b228-e063-6394a90a593d			339d8f89-3640-b7ca-e063-6394a90a6052	2023-01-01	Warnings	Exact identifier spl id: 339d9469-f095-b228-e063-6394a90a593d spl set id: 339d8f89-3640-b7ca-e063-6394a90a6052

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.