Label: NICOTINE patch
- NDC Code(s): 70677-0030-1, 70677-0031-1, 70677-0032-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient Step One (in each patch)
- Active ingredient Step Two (in each patch)
- Active ingredient Step Three (in each patch)
- Purpose
- Uses
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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.
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
- do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.
- if you have vivid dreams or other sleep disturbances, remove this patch at bedtime
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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 orless 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 used patch 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
- Inactive ingredients
- Comments or questions?
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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.
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PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON
Principal Display Panel - Step 1 – 21 mg Carton Label
McKesson SunMark ®
NDC 70677-0032-1
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
14 Patches
*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.
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PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON
Principal Display Panel - Step 2 – 14 mg Carton Label
McKesson SunMark ®
NDC 70677-0031-1
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
14 Patches
*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.
-
PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON
Principal Display Panel - Step 3 – 7 mg Carton Label
McKesson SunMark ®
NDC 70677-0030-1
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
14 Patches
*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.
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INGREDIENTS AND APPEARANCE
NICOTINE
nicotine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0031 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:70677-0031-1 14 in 1 CARTON 12/04/2017 1 1 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 12/04/2017 NICOTINE
nicotine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0030 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:70677-0030-1 14 in 1 CARTON 12/04/2017 1 1 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 12/04/2017 NICOTINE
nicotine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0032 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:70677-0032-1 14 in 1 CARTON 12/04/2017 1 1 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 12/04/2017 Labeler - Strategic Sourcing Services LLC (116956644) Establishment Name Address ID/FEI Business Operations Aveva Drug Delivery Systems 783982093 manufacture(70677-0030, 70677-0031, 70677-0032) , analysis(70677-0030, 70677-0031, 70677-0032)