Nicotine Transdermal System

Nicotine by

Drug Labeling and Warnings

Nicotine by is a Otc medication manufactured, distributed, or labeled by Praxis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NICOTINE- nicotine patch 
Praxis, LLC

----------

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 1-800-222-1222 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 2for 6 weeks, then Step 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 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

Comments or questions?

1-877-748-1970

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.

  • 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.

See bottom panel for lot number and expiration date.

*This product is not manufactured or distributed by Dr. Reddy's Laboratories Ltd., distributor of Habitrol®.

AVEVA

A DifGen Company

Distributed by:

RUGBY ®LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

rev. 12/23

PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON

Rugby ®

NDC: 0536-5896-53

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL ®*

Clear

Nicotine

Transdermal System 

Patch

21 mg

21 mg delivered over 24 hours

STOP SMOKING AID

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.

*Habitrol ®is a registered trademark of Novartis Consumer Health, Inc.

STEP ONE

7

PATCHES

Step 1

PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON

Rugby ®

NDC: 0536-5895-53

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

Patch

14 mg

14 mg delivered over 24 hours

STOP SMOKING AID

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.

*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.

STEP TWO

7

PATCHES

Step 2

PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON

Rugby ®

NDC: 0536-5894-53

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

Patch

7 mg

7 mg delivered over 24 hours

STOP SMOKING AID

Includes Behavior Support Program with Self-Help Guide

For use after completing Step 2

*Habitrol ®is a registered trademark of Novartis Consumer Health, Inc.

STEP THREE

7

PATCHES

Step 3

NICOTINE 
nicotine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59368-362
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: 59368-362-017 in 1 CARTON06/25/2024
11 h in 1 POUCH; Type 0: Not a Combination Product
2NDC: 59368-362-0314 in 1 CARTON06/25/2024
21 h in 1 POUCH; Type 0: Not a Combination Product
3NDC: 59368-362-0228 in 1 CARTON06/25/2024
31 h in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461206/25/2024
NICOTINE 
nicotine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59368-361
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: 59368-361-017 in 1 CARTON06/25/2024
11 h in 1 POUCH; Type 0: Not a Combination Product
2NDC: 59368-361-0314 in 1 CARTON06/25/2024
21 h in 1 POUCH; Type 0: Not a Combination Product
3NDC: 59368-361-0228 in 1 CARTON06/25/2024
31 h in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461206/25/2024
NICOTINE 
nicotine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59368-360
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: 59368-360-017 in 1 CARTON06/25/2024
11 h in 1 POUCH; Type 0: Not a Combination Product
2NDC: 59368-360-0214 in 1 CARTON06/25/2024
21 h in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07461206/25/2024
Labeler - Praxis, LLC (016329513)
Establishment
NameAddressID/FEIBusiness Operations
Praxis, LLC016329513manufacture(59368-360, 59368-361, 59368-362) , label(59368-360, 59368-361, 59368-362) , pack(59368-360, 59368-361, 59368-362)

Revised: 1/2023
Document Id: 3388ad1d-4e59-7eea-e063-6294a90a33b9
Set id: 33889b33-1f71-74fe-e063-6294a90af290
Version: 1
Effective Time: 20230101
 

Trademark Results [Nicotine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NICOTINE
NICOTINE
87518792 5591301 Live/Registered
Nicotine LLC
2017-07-07
NICOTINE
NICOTINE
75604258 not registered Dead/Abandoned
King, Jesse
1998-12-14
NICOTINE
NICOTINE
75604258 not registered Dead/Abandoned
Brazie, Sean
1998-12-14
NICOTINE
NICOTINE
75604258 not registered Dead/Abandoned
Johnson, John
1998-12-14
NICOTINE
NICOTINE
75604258 not registered Dead/Abandoned
Crouch, Richard
1998-12-14
NICOTINE
NICOTINE
75063628 2027268 Dead/Cancelled
ECI, INC.
1996-02-26
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