Nicotine Transdermal System

Nicotine Transdermal System by

Drug Labeling and Warnings

Nicotine Transdermal System by is a Otc medication manufactured, distributed, or labeled by Aveva Drug Delivery Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NICOTINE TRANSDERMAL SYSTEM- nicotine transdermal system patch 
Aveva Drug Delivery Systems, Inc.

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Nicotine Transdermal System

Drug Facts

Active ingredient (in each patch)

Nicotine, 21 mg delivered over 24 hours

Active ingredient (in each patch)

Nicotine, 14 mg delivered over 24 hours

Active ingredient (in each patch)

Nicotine, 7 mg delivered over 24 hours

Purpose

Stop smoking aid

Use

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

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 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

  • 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

  • if you have vivid dreams or other sleep disturbances, remove the patch at bedtime

Stop use and ask a doctor if

  • 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.

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

  • 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 2 for 6 weeks, then Step 3 for 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

  • store at 20°C - 25°C (68°F - 77°F)

Inactive ingredients

acrylate adhesive, polyester, silicone adhesive

Questions or comments?

1-888-889-8893

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 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.

  • 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.

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

Do not use if individual pouch is open or torn.

See self-help guide inside.

*Quitine Circle™ is an optional community support program and is not related to the therapeutic effect, treatment duration, or clinical outcomes of this product.

Distributed by:
QUITINE LLC
Lewes, DE, 19958

Rev. 12/2025

PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg 14 CARTON

NDC: 3215-1206-14

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 deliverd over 24 hours 

21 mg, 14's CARTON

PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON

NDC: 3215-1205-14

Quitine

NICOTINE TRANSDERMAL SYSTEM PATCH

STOP SMOKING AID

STEP TWO

14 mg

14 CLEAR PATCHES 

2 week kit 

If you smoke  MOREthan 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 deliverd over 24 hours 

14 mg CARTON

PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON

NDC: 3215-1204-14

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 deliverd over 24 hours 

7 mg CARTON

NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 3215-1206
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE21 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 3215-1206-1414 in 1 CARTON02/18/202604/01/2026
11 h in 1 PATCH; Type 0: Not a Combination Product
2NDC: 3215-1206-2828 in 1 CARTON02/18/202604/01/2026
21 h in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461202/18/202604/01/2026
NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 3215-1205
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 3215-1205-1414 in 1 CARTON02/18/202604/01/2026
11 h in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461202/18/202604/01/2026
NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 3215-1204
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE7 mg  in 24 h
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 3215-1204-1414 in 1 CARTON02/18/202604/01/2026
11 h in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461202/18/202604/01/2026
Labeler - Aveva Drug Delivery Systems, Inc. (783982093)

Revised: 4/2026