FDA.reportPublic FDA data

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 20:39:32

Label at a glance#

ProductNicotine Transdermal System
Active ingredientNICOTINE
Label structure18 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 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 pa...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 21 mg delivered over 24 hours

Active ingredient (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 14 mg delivered over 24 hours

Active ingredient (in each patch)

OTC - ACTIVE INGREDIENT SECTION

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

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 have skin problems, because you are more likely to get rashes.
  • stomach ulcer or diabetes
  • history of seizures

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

  • if you have vivid dreams or other sleep disturbances, remove the 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
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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 you smoke more than 10 cigarettes per day, use the following schedule below:
Weeks 1 thru 4Weeks 5 and 6 Weeks 7 and 8
 Step 1Step 2Step 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 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

Questions or comments?

OTC - QUESTIONS SECTION

1-877-748-1970

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.

SPL UNCLASSIFIED SECTION

  • Not for sale to persons 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.

*This product is not manufactured or distributed by Dr. Reddy's Laboratories Ltd., distributor of Habitrol.

Distributed By

AmerisourceBergen
1 West First Avenue,
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com

SPL UNCLASSIFIED SECTION

For your family’s protection, patches are supplied in child-resistant pouches.

Do not use if individual pouch is open or torn.

See bottom panel for lot number and expiration date.

See self-help guide inside.

Mfd. by:

AVEVA

DRUG DELIVERY SYSTEM

A DifGen Company

Miramar, FL 33025

Rev. 12/2023

PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg 7 CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY ®

Compare to active ingredient in Habitrol ®*

NDC 46122-568-07

Clear

Nicotine

Transdermal

System Patch

21 mg delivered over 24 hours

STEP 1 - Stop Smoking Aid

Includes Behavior Support Program with Self-help Guide

If you smoke Morethan 10 cigarettes per day: Start with Step 1.

If you smoke 10 or Lesscigarettes per day: Start with Step 2.

21mg  - 7 Patches

21 mg, 7's CARTON21 mg, 7's CARTON

PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg 14 CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY ®

Compare to active ingredient in Habitrol ®*

NDC 6122-353-74

Clear

Nicotine

Transdermal

System Patch

21 mg delivered over 24 hours

STEP 1 - Stop Smoking Aid

Includes Behavior Support Program with Self-help Guide

If you smoke Morethan 10 cigarettes per day: Start with Step 1.

If you smoke 10 or Lesscigarettes per day: Start with Step 2.

21mg - 14Patches

21 mg, 14's CARTON21 mg, 14's CARTON

PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY ®

Compare to active ingredient in Habitrol ®*

NDC 6122-352-74

Clear

Nicotine

Transdermal

System Patch

14 mg delivered over 24 hours

STEP 2 - Stop Smoking Aid

Includes Behavior Support Program with Self-help Guide

If you smoke Morethan 10 cigarettes per day: Start with Step 1.

If you smoke 10 or Lesscigarettes per day: Start with Step 2.

14mg - 14Patches

14 mg CARTON14 mg CARTON

PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY ®

Compare to active ingredient in Habitrol ®*

NDC 6122-354-74

Clear

Nicotine

Transdermal

System Patch

7 mg delivered over 24 hours

STEP 3 - Stop Smoking Aid

Includes Behavior Support Program with Self-help Guide

For use after completing Step 2.

7mg - 14Patches

7 mg CARTON7 mg CARTON

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59368-344NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250425_33778632-3b8a-7eff-e063-6394a90ac83b.zip
59368-345NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250425_33778632-3b8a-7eff-e063-6394a90ac83b.zip
59368-346NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [PRAXIS, LLC]1Unmatched20250425_33778632-3b8a-7eff-e063-6394a90ac83b.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59368-34459368-344-01
59368-34559368-345-01
59368-34659368-346-01

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
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
NICOTINE6M3C89ZY6RACTIB
DIMETHICONE92RU3N3Y1OIACT
NICOTINE6M3C89ZY6RACTIB
DIMETHICONE92RU3N3Y1OIACT
NICOTINE6M3C89ZY6RACTIB

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
337782f5-1dd4-55f0-e063-6294a90a3eb233778632-3b8a-7eff-e063-6394a90ac83b2023-01-01WarningsExact identifier
spl id: 337782f5-1dd4-55f0-e063-6294a90a3eb2
spl set id: 33778632-3b8a-7eff-e063-6394a90ac83b

Reported adverse events (FAERS/openFDA)#

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