Nicotine Transdermal System Patch, Extended Release
FDA Label NDC 36800-032

17 label sections · Submitted to the FDA by Topco Associates Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Nicotine Transdermal System (NDC 36800-032). 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 Carton

NDC 36800-038-14

TopCarehealth ®

COMPARE TO HABITROL ®​ ACTIVE INGREDIENT*

Clear

Nicotine

Transdermal System 

Patch

21 mg DELIVERED OVER 24 HOURS

STOP SMOKING AID

Includes Behavior Support
Program with Self-Help Guide

IF YOU SMOKE MORE THAN
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)

21 mg Carton (21 mg Step 01)

21 mg Carton (21 mg Step 01)

Principal Display Panel - Step Two 14 Mg Carton

NDC 36800-034-14

TopCarehealth ®

COMPARE TO HABITROL ®ACTIVE INGREDIENT*

Clear

Nicotine

Transdermal System

Patch

14 mg DELIVERED OVER 24 HOURS

STOP SMOKING AID

Includes Behavior Support
Program with Self-Help Guide

IF YOU SMOKE MORE THAN
10 CIGARETTES PER DAY:
START WITH STEP 1

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

STEP 2 14 mg

14 CLEAR
PATCHES
(2-WEEK KIT)

14 mg Carton (14 mg Step 02)

14 mg Carton (14 mg Step 02)

Principal Display Panel - Step Three 7 Mg Carton

NDC 36800-032-14

TopCarehealth ®

COMPARE TO HABITROL ®ACTIVE INGREDIENT*

Clear

Nicotine

Transdermal System

Patch

7 mg DELIVERED OVER 24 HOURS

STOP SMOKING AID

Includes Behavior Support
Program with Self-Help Guide

FOR USE AFTER
COMPLETING STEP 2

STEP 3 7 mg

14 CLEAR
PATCHES
(2-WEEK KIT)

7 mg Carton (7 mg Step 03)

7 mg Carton (7 mg Step 03)

* Please review the disclaimer below.