Nicotine Transdermal System Patch
FDA Label NDC 3215-0121

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aveva Drug Delivery Systems, Inc. for the product Nicotine Transdermal System (NDC 3215-0121). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each patch), purpose, use, otc - pregnancy or breast feeding, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Patch)

Nicotine, 21 mg delivered over 24 hours

Nicotine, 14 mg delivered over 24 hours

Nicotine, 7 mg delivered over 24 hours

To Increase Your Success In Quitting:

  • You must be motivated to quit.
  • Use one patch daily according to directions.
  • 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.
  • Use patch with a behavioral support program, such as the one described in the enclosed booklet.

Principal Display Panel - Step One 21 Mg 14 Carton

NDC 3215-0122-14

Nicotine

Nicotine Transdermal System 21 mg delivered over 24 hours

STOP SMOKING AID

CLEAR PATCH

EXTENDED RELEASE

24 HOURS

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.

STEP 1

21 mg

14 clear patches (2 week kit)

COMPARE TO HABITROL ®

active ingredient*

21 mg, 14's Carton (Image001)

21 mg, 14's Carton (Image001)

Principal Display Panel - Step Two 14 Mg Carton

NDC 3215-0121-14

Nicotine

Nicotine Transdermal System 14 mg delivered over 24 hours

STOP SMOKING AID

CLEAR PATCH

EXTENDED RELEASE

24 HOURS

Includes Behavior Support Program with Self-help Guide

If you smoke MOREthan 10 cigarettes per day:
Use after completing Step 1.
If you smoke 10 or LESScigarettes per day:
Start with Step 2.

STEP 2

14 mg

14 clear patches

(2 week kit)

COMPARE TO HABITROL ®

active ingredient*

14 mg Carton (Image002)

14 mg Carton (Image002)

Principal Display Panel - Step Three 7 Mg Carton

NDC 3215-0120-14

Nicotine

Nicotine Transdermal System 7 mg delivered over 24 hours

STOP SMOKING AID

CLEAR PATCH

EXTENDED RELEASE

24 HOURS

Includes Behavior Support Program with Self-help Guide

For use after completing step 2

STEP 3

7 mg

14 clear patches

(2 week kit)

COMPARE TO HABITROL ®

active ingredient*

7 mg Carton (Image003)

7 mg Carton (Image003)

* Please review the disclaimer below.