OTC Medication Information: Nicotine

NICOTINE- nicotine patch
Apotex Corp.

Drug Facts

Active ingredient Step One (in each patch)

Nicotine, 21 mg delivered over 24 hours

Active ingredient Step Two (in each patch)

Nicotine, 14 mg delivered over 24 hours

Active ingredient Step Three (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 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 this patch at bedtime

Stop use and ask a doctor if

  • Skin redness caused by the patch does not go away after four days, or 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 used patch 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 4 Weeks 5 and 6 Weeks 7 and 8
STEP 1 STEP 2 STEP 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

Comments or questions?

1-844-562-7963

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.

PRINCIPAL DISPLAY PANEL — STEP ONE 21 mg CARTON

Principal Display Panel — Step 1 – 21 mg Carton Label

Justwell

NDC 60505-7093-2

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

21 mg delivered over 24 hours

STOP SMOKING AID

21 mg

Includes Behavior Support Program with Self-Help Guide

STEP ONE

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

28 Patches

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

nicotine-transdermal-system-21mg-carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — STEP TWO 14 mg CARTON

Principal Display Panel — Step 2 – 14 mg Carton Label

Justwell

NDC 60505-7092-2

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

14 mg delivered over 24 hours

STOP SMOKING AID

14 mg

Includes Behavior Support Program with Self-Help Guide

STEP ONE

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

28 Patches

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

nicotine-transdermal-system-14mg-carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — STEP THREE 7 mg CARTON

Principal Display Panel — Step 3 – 7 mg Carton Label

Justwell

NDC 60505-7091-2

COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*

Clear

Nicotine

Transdermal System

7 mg delivered over 24 hours

STOP SMOKING AID

7 mg

Includes Behavior Support Program with Self-Help Guide

STEP ONE

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

28 Patches

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

nicotine-transdermal-system-7mg-carton
(click image for full-size original)
NICOTINE
nicotine patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-7091
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 7 mg in 24 h
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-7091-2 28 POUCH in 1 CARTON contains a POUCH
1 1 h in 1 POUCH This package is contained within the CARTON (60505-7091-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074612 01/24/2020
NICOTINE
nicotine patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-7092
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 14 mg in 24 h
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-7092-2 28 POUCH in 1 CARTON contains a POUCH
1 1 h in 1 POUCH This package is contained within the CARTON (60505-7092-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074612 01/24/2020
NICOTINE
nicotine patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-7093
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 21 mg in 24 h
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-7093-2 28 POUCH in 1 CARTON contains a POUCH
1 1 h in 1 POUCH This package is contained within the CARTON (60505-7093-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074612 01/24/2020
Labeler — Apotex Corp. (845263701)

Revised: 11/2022 Apotex Corp.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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