NICOTINE TRANSDERMAL SYSTEM patch

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., DifGen Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 (1-800-222-1222). 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°C-25°C (68°F-77°F)

Inactive ingredients

acrylate adhesive, polyester, silicone adhesive

Questions or comments?

1-888-333-6127

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.

SPL UNCLASSIFIED SECTION

• 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 ®.

Mfd. by:

AVEVA DRUG DELIVERY SYSTEM 

A DifGenCompany

Miramar, FL 33025

MADE IN USA

SPL UNCLASSIFIED SECTION

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

DO NOT USE IF INDIVIDUAL POUCH IS OPEN OR TORN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

See self-help guide inside.

See bottom panel for lot number and expiration date.

Rev. 07/25

PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON

NDC 3215-1203-07

COMPARE TO HABITROL ®​ ACTIVE INGREDIENT*

CLEAR

Nicotine

Transdermal System Patch

21 mgdeliveredover24 hours

STOP SMOKING AID

Includes:

Behavior support program with self-help guide

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.

STEP 1

21 mg - 14 PATCHES

PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON

NDC 3215-1202-07

COMPARE TO HABITROL ® ACTIVE INGREDIENT*

CLEAR

Nicotine

Transdermal System Patch

14 mg delivered over 24 hours

STOP SMOKING AID

Includes:

Behavior support program with self-help guide

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

STEP 2

14 mg - 14 PATCHES

PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON

NDC 3215-1201-07

COMPARE TO HABITROL ®ACTIVE INGREDIENT*

CLEAR

Nicotine

Transdermal System Patch

14 mg delivered over 24 hours

STOP SMOKING AID

Includes:

Behavior support program with self-help guide

For use after completing step 2

STEP 3

7 mg - 14 PATCHES

INGREDIENTS AND APPEARANCE

NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 3215-1203
Route of Administration	TRANSDERMAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 3215-1203-07	7 in 1 CARTON	06/25/2024
1		24 h in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 3215-1203-14	14 in 1 CARTON	06/25/2024
2		24 h in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 3215-1203-28	28 in 1 CARTON	06/25/2024
3		24 h in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074612	06/25/2024

NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 3215-1202
Route of Administration	TRANSDERMAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 3215-1202-07	7 in 1 CARTON	06/25/2024
1		24 h in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 3215-1202-14	14 in 1 CARTON	06/25/2024
2		24 h in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 3215-1202-28	28 in 1 CARTON	06/25/2024
3		24 h in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074612	06/25/2024

NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 3215-1201
Route of Administration	TRANSDERMAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 3215-1201-07	7 in 1 CARTON	06/25/2024
1		24 h in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 3215-1201-14	14 in 1 CARTON	06/25/2024
2		24 h in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074612	06/25/2024

Labeler - Aveva Drug Delivery Systems Inc. (783982093)

Registrant - DifGen Pharmaceuticals LLC (118801101)

Establishment
Name	Address	ID/FEI	Business Operations
Aveva Drug Delivery Systems Inc.		783982093	manufacture(3215-1203, 3215-1202, 3215-1201)