Nicotine Transdermal System Patch
FDA Label NDC 84720-121

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quitine Llc for the product Nicotine Transdermal System (NDC 84720-121). 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 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 84720-122-14

Quitine

NICOTINE TRANSDERMAL SYSTEM PATCH

STOP SMOKING AID

STEP ONE

21 mg

14 CLEAR PATCHES 

2 week kit 

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.

Free access to the Quitine Circle TM* 

A supportive quite community 

21 mg delivered over 24 hours 

21 mg, 14's Carton (Image001)

21 mg, 14's Carton (Image001)

Principal Display Panel - Step One 21 Mg 28 Carton

NDC 84720-122-28

Quitine

NICOTINE TRANSDERMAL SYSTEM PATCH

STOP SMOKING AID

STEP ONE

21 mg

28 CLEAR PATCHES

2 week kit

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

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

Free access to the Quitine Circle TM*

A supportive quite community

21 mg delivered over 24 hours

21 mg, 28's Carton (Image002)

21 mg, 28's Carton (Image002)

Principal Display Panel - Step Two 14 Mg Carton

NDC 84720-121-14

Quitine

NICOTINE TRANSDERMAL SYSTEM PATCH

STOP SMOKING AID

STEP TWO

14 mg

14 CLEAR PATCHES 

2 week kit 

If you smoke  MORE than 10 cigarettes per day: Use after completing Step 1.

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

Free access to the Quitine Circle TM* 

A supportive quite community 

14 mg delivered over 24 hours 

14 mg, 14's Carton (Image003)

14 mg, 14's Carton (Image003)

Principal Display Panel - Step Three 7 Mg Carton

NDC 84720-120-14

Quitine

NICOTINE TRANSDERMAL SYSTEM PATCH

STOP SMOKING AID

STEP THREE

7 mg

14 CLEAR PATCHES 

2 week kit 

For use sfter completing Step 2.

Free access to the Quitine Circle TM* 

A supportive quite community 

7 mg delivered over 24 hours 

7 mg, 14's Carton (Image004)

7 mg, 14's Carton (Image004)

* Please review the disclaimer below.