Nicotine Transdermal System Patch

Nicotine Transdermal System Patch
SPL v8
SPL
SPL Set ID c4cc8321-807f-258f-71f5-e993f633f9e3
Route
TRANSDERMAL
Published
Effective Date 2024-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nicotine (21 mg)
Inactive Ingredients
Dimethicone

Identifiers & Packaging

Marketing Status
ANDA Active Since 2024-09-01

Description

Nicotine, 21 mg delivered over 24 hours

Purpose

Stop smoking aid


Medication Information

Purpose

Stop smoking aid

Description

Nicotine, 21 mg delivered over 24 hours

Use

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

Section 42229-5

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.

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

See bottom panel for lot number and expiration date.

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.

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.

Active Ingredient 

Nicotine, 21 mg delivered over 24 hours

Inactive Ingredients

acrylate adhesive, polyester, silicone adhesive

Other Information  
  • store at 20ºC–25ºC (68ºF–77ºF)
Questions Or Comments?

877-748-1970

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 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 dissficulty breathing or rash)
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
Principal Display Panel 7 Mg Carton

LEADER TM

COMPARE TO HABITROL ® active ingredient *

NDC 70000-0510-1

CLEAR

Nicotine Transdermal System Patch

7 mg Delivered Over 24 Hours | Stop Smoking Aid

7 mg

STEP 3

Includes Behavior Support Program with SELF-HELP GUIDE



For Use After Completing Step 2.

7 PATCHES (1 WEEK KIT)

100% Money Back Guarantee

Principal Display Panel 14 Mg Carton

LEADER TM

COMPARE TO HABITROL ® active ingredient *

NDC 70000-0511-1

CLEAR

Nicotine Transdermal System Patch

14 mg Delivered Over 24 Hours | Stop Smoking Aid

14 mg

STEP 2

Includes Behavior Support Program with SELF-HELP GUIDE



If You Smoke MOREThan 10 Cigarettes per Day:

Use after Completing Step 1.

If You Smoke 10 or LESSCigarettes per Day:

Start with Step 2.

7 PATCHES (1 WEEK KIT)

100% Money Back Guarantee

Principal Display Panel 21 Mg Carton

LEADER TM

COMPARE TO HABITROL ®active ingredient *

NDC 70000-0512-1

CLEAR

Nicotine Transdermal System Patch

21 mg Delivered Over 24 Hours | Stop Smoking Aid

21 mg

STEP 1

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.

7 PATCHES (1 WEEK KIT)

100% Money Back Guarantee

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.

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.

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.


Structured Label Content

Use

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

Section 42229-5 (42229-5)

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.

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

See bottom panel for lot number and expiration date.

Purpose

Stop smoking aid

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.

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.

Active Ingredient  (Active ingredient )

Nicotine, 21 mg delivered over 24 hours

Inactive Ingredients (Inactive ingredients)

acrylate adhesive, polyester, silicone adhesive

Other Information   (Other information  )
  • store at 20ºC–25ºC (68ºF–77ºF)
Questions Or Comments? (Questions or comments?)

877-748-1970

When Using This Product (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 (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 dissficulty breathing or rash)
Ask A Doctor Before Use If You Have (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
Principal Display Panel 7 Mg Carton (PRINCIPAL DISPLAY PANEL- 7 mg CARTON)

LEADER TM

COMPARE TO HABITROL ® active ingredient *

NDC 70000-0510-1

CLEAR

Nicotine Transdermal System Patch

7 mg Delivered Over 24 Hours | Stop Smoking Aid

7 mg

STEP 3

Includes Behavior Support Program with SELF-HELP GUIDE



For Use After Completing Step 2.

7 PATCHES (1 WEEK KIT)

100% Money Back Guarantee

Principal Display Panel 14 Mg Carton (PRINCIPAL DISPLAY PANEL - 14 mg CARTON)

LEADER TM

COMPARE TO HABITROL ® active ingredient *

NDC 70000-0511-1

CLEAR

Nicotine Transdermal System Patch

14 mg Delivered Over 24 Hours | Stop Smoking Aid

14 mg

STEP 2

Includes Behavior Support Program with SELF-HELP GUIDE



If You Smoke MOREThan 10 Cigarettes per Day:

Use after Completing Step 1.

If You Smoke 10 or LESSCigarettes per Day:

Start with Step 2.

7 PATCHES (1 WEEK KIT)

100% Money Back Guarantee

Principal Display Panel 21 Mg Carton (PRINCIPAL DISPLAY PANEL - 21 mg CARTON)

LEADER TM

COMPARE TO HABITROL ®active ingredient *

NDC 70000-0512-1

CLEAR

Nicotine Transdermal System Patch

21 mg Delivered Over 24 Hours | Stop Smoking Aid

21 mg

STEP 1

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.

7 PATCHES (1 WEEK KIT)

100% Money Back Guarantee

Keep Out of Reach of Children and Pets. (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.

To Increase Your Success in Quitting:  (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.

Ask A Doctor Or Pharmacist Before Use If You Are (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.


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Raw Label Data

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