Nicotine Transdermal System

Manufacturer
Praxis, LLC
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:39:29

Label at a glance#

ProductNicotine Transdermal System Step 3
Active ingredientNICOTINE
Label structure12 sections

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 2 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...

Label contents#

Full prescribing information#

Active ingredient(in each patch)  

OTC - ACTIVE INGREDIENT SECTION

Step 1 - Nicotine, 21 mg delivered over 24 hours

Step 2 - Nicotine, 14 mg delivered over 24 hours

Step 3 - Nicotine, 7 mg delivered over 24 hours

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS 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 have 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 blood stream 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 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

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 the used patches 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 yousmoke more than 10 cigarettes per day,use the following schedule below:
    Weeks 1 thru 2Weeks 5 and 6Weeks 7 and 8
    Step 1Step 2Step 3
    Use one 21 mg patch/dayUse one 14 mg patch/dayUse 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 the used patches 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?

OTC - QUESTIONS 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 - 7 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Transdermal System

NDC No. 68016-290-88

14 Patches

7mgcarton.jpg7mgcarton.jpg

PRINCIPAL DISPLAY PANEL - 14 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Transdermal System

NDC No. 68016-289-88

14 Patches

14mgcarton.jpg14mgcarton.jpg

PRINCIPAL DISPLAY PANEL- 21 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Transdermal System

NDC No. 68016-288-88

14 Patches

21mgcarton.jpg21mgcarton.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-353NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250426_33882cd8-810c-00cd-e063-6394a90a40d1.zip
59368-354NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250426_33882cd8-810c-00cd-e063-6394a90a40d1.zip
59368-355NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250426_33882cd8-810c-00cd-e063-6394a90a40d1.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59368-35359368-353-01
59368-35459368-354-01
59368-35559368-355-01

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
33882cd8-810d-00cd-e063-6394a90a40d133882cd8-810c-00cd-e063-6394a90a40d12023-01-01WarningsExact identifier
spl id: 33882cd8-810d-00cd-e063-6394a90a40d1
spl set id: 33882cd8-810c-00cd-e063-6394a90a40d1

Reported adverse events (FAERS/openFDA)#

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