NICOTINE TRANSDERMAL SYSTEM patch, extended release

Drug Details [pdf]

Drug Fact
Active ingredient(in each patch)

Step 1 - Nicotine, 21 mg delivered over 24 hours

Step 2 - Nicotine, 14 mg delivered over 24 hours

Step 3 - 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 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 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 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 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 οC – 25 οC (68 οF – 77 οF)
Inactive ingredients

acrylate adhesive, polyester, silicone adhesive
Questions or comments?

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

See self-help guide inside.

See bottom panel for lot number and expiration date.

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

Do not use if individual pouch is open or torn.

Manufactured by:
AVEVA Drug Delivery Systems
A DifGen Company
Miramar, FL 33025

For BluePoint Laboratories

Rev. 12/23
PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON

NDC: 68001-434-88

compare to the active ingredient in Habitrol ®*

Clear
Nicotine Transdermal
System Patch

Stop Smoking Aid

Includes Behavior Support Program with Self-Help Guide

21 mg

21 mg delivered over 24 hours

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

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

The full treatment course for STEP 1 is 28 patches (4 weeks); this package contains 7 patches (1 week course) only. Read the enclosed self-help guide for additional information.

STEP 1
7 Clear Patches
(1 Week Kit)

NDC: 68001-434-90

STEP 1
14 Clear Patches
(2 Week Kit)

NDC: 68001-434-91

STEP 1
28 Clear Patches
(4 Week Kit)
PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON

NDC: 68001-433-88

compare to the active ingredient in Habitrol ®*

Clear
Nicotine Transdermal
System Patch

Stop Smoking Aid

Includes Behavior Support Program with Self-Help Guide

14 mg

14 mg delivered over 24 hours

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

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

The full treatment course for STEP 2 is 2 or 6 weeks (depending on how many cigarettes you smoke per day; this package contains 7 patches (1 week course) only. Read enclosed self-help guide for additional information.

STEP 2
7 Clear Patches
(1 Week Kit)

NDC: 68001-433-90

STEP 2
14 Clear Patches
(2 Week Kit)
PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON

NDC: 68001-432-88

compare to the active ingredient in Habitrol ®*

Clear
Nicotine Transdermal
System Patch

Stop Smoking Aid

Includes Behavior Support Program with Self-Help Guide

7 mg

21 mg delivered over 24 hours

For use after completing step 2.

The full treatment course for STEP 3 is 14 patches (2 weeks); this package contains 7 patches (1 week course) only. Read the enclosed self-help guide for additional information.

STEP 3
7 Clear Patches
(1 Week Kit)

NDC: 68001-432-90

STEP 3
14 Clear Patches
(2 Week Kit)

INGREDIENTS AND APPEARANCE

NICOTINE TRANSDERMAL SYSTEM
nicotine transdermal system patch, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-434
Route of Administration	TRANSDERMAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	21 mg in 24 h

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 68001-434-88	7 in 1 CARTON	06/27/2024
1		1 h in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 68001-434-90	14 in 1 CARTON	06/27/2024
2		1 h in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 68001-434-91	28 in 1 CARTON	06/27/2024
3		1 h in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074612	06/27/2024

NICOTINE TRANSDERMAL SYSTEM
nicotine transdermal system patch, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-432
Route of Administration	TRANSDERMAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	7 mg in 24 h

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 68001-432-88	7 in 1 CARTON	06/27/2024
1		1 h in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 68001-432-90	14 in 1 CARTON	06/27/2024
2		1 h in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074612	06/27/2024

NICOTINE TRANSDERMAL SYSTEM
nicotine transdermal system patch, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-433
Route of Administration	TRANSDERMAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	14 mg in 24 h

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 68001-433-88	7 in 1 CARTON	06/27/2024
1		1 h in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 68001-433-90	14 in 1 CARTON	06/27/2024
2		1 h in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074612	06/27/2024

Labeler - BluePoint Laboratories (985523874)

NICOTINE TRANSDERMAL SYSTEM patch, extended release

Nicotine Transdermal System by

Drug Labeling and Warnings

Drug Details [pdf]

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

Keep out of reach of children and pets.

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