NICOTINE TRANSDERMAL SYSTEM- nicotine transdermal system patch, extended release 
Topco Associates LLC

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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 right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

Directions

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

Other information

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.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007
©TOPCO QHPA1220
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com

Scan here for more information or call 1-888-423-0139

Rev. 12/2023

See Self-Help Guide Inside.

FOR YOUR FAMILY’S PROTECTION, PATCHES ARE SUPPLIED IN CHILD-RESISTANT POUCHES.

DO NOT USE IF INDIVIDUAL POUCH IS OPEN OR TORN.

This TopCare ®product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

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.

PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON

NDC 36800-038-14

TopCarehealth ®

COMPARE TO HABITROL ®​ ACTIVE INGREDIENT*

Clear

Nicotine

Transdermal System 

Patch

21 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 LESScigarettes
per day: Start with Step 2

STEP 1   21 mg 

14 CLEAR
PATCHES
(2-WEEK KIT)

21 mg CARTON

PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON

NDC 36800-034-14

TopCarehealth ®

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 LESScigarettes
per day: Start with Step 2

STEP 2 14 mg

14 CLEAR
PATCHES
(2-WEEK KIT)

14 mg CARTON

PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON

NDC 36800-032-14

TopCarehealth ®

COMPARE TO HABITROL ®ACTIVE INGREDIENT*

Clear

Nicotine

Transdermal System

Patch

7 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 CLEAR
PATCHES
(2-WEEK KIT)

7 mg CARTON

NICOTINE TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-038
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:36800-038-1414 in 1 CARTON06/25/2024
11 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 TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-034
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:36800-034-1414 in 1 CARTON06/25/2024
11 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 TRANSDERMAL SYSTEM 
nicotine transdermal system patch, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-032
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:36800-032-1414 in 1 CARTON06/25/2024
11 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 - Topco Associates LLC (006935977)

Revised: 6/2024
Document Id: 1b665646-faff-05d5-e063-6294a90ae1ae
Set id: a631d31d-38e6-1772-8b6d-57672b785d98
Version: 8
Effective Time: 20240621
 
Topco Associates LLC