MedPath

Nicotine

Nicotine Transdermal System

Approved
Approval ID

a08022ff-e412-47f9-8132-318f55528c5c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

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
NDC Product Code70677-0031
Application NumberANDA074612
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (2)

DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
NICOTINEActive
Quantity: 14 mg in 24 h
Code: 6M3C89ZY6R
Classification: ACTIB

Nicotine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70677-0032
Application NumberANDA074612
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (2)

DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
NICOTINEActive
Quantity: 21 mg in 24 h
Code: 6M3C89ZY6R
Classification: ACTIB

Nicotine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70677-0030
Application NumberANDA074612
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (2)

DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
NICOTINEActive
Quantity: 7 mg in 24 h
Code: 6M3C89ZY6R
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/19/2017

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.

![nicotine-transdermal-system-three- carton.jpg](/dailymed/image.cfm?name=nicotine-transdermal-system-three- carton.jpg&id=890085)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/3/2017

Uses

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/3/2017

Purpose

Stop smoking aid

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/3/2017

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

LOINC: 34068-7Updated: 7/19/2017

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

LOINC: 55106-9Updated: 5/3/2017

Active ingredient Step Three (in each patch)

Nicotine, 7 mg delivered over 24 hours

WARNINGS SECTION

LOINC: 34071-1Updated: 5/3/2017

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

LOINC: 51727-6Updated: 5/3/2017

Inactive ingredients

acrylate adhesive, polyester, silicone adhesive

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Nicotine - FDA Drug Approval Details