Label: NICOTINE TRANSDERMAL SYSTEM kit

  • NDC Code(s): 11822-1600-0, 11822-1601-0, 11822-1602-0, 11822-1603-1
  • Packager: Rite Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 13, 2023

If you are a consumer or patient please visit this version.

  • 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.

    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 blood stream for several hours after you take off the patch.
    • 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

    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 4Weeks 5 and 6Weeks 7 and 8
      Step 1Step 2Step 3
      Use one 21 mg patch/dayUse one 14 mg patch/dayUse 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

  • Comments or Questions?

    1-844-562-7963

  • 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.

  • PRINCIPAL DISPLAY PANEL-56 count CARTON

    Nicotine Transdermal System

    NDC No. 11822-1603-1

    56 Patches

    56 count CTN.jpg

  • INGREDIENTS AND APPEARANCE
    NICOTINE TRANSDERMAL SYSTEM 
    nicotine transdermal system kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1603
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1603-11 in 1 CARTON; Type 1: Convenience Kit of Co-Package09/15/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 128 POUCH 28 
    Part 214 POUCH 14 
    Part 314 POUCH 14 
    Part 1 of 3
    NICOTINE TRANSDERMAL SYSTEM 
    nicotine transdermal system patch, extended release
    Product Information
    Item Code (Source)NDC:11822-1602
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE21 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1602-01 in 1 POUCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461209/15/2021
    Part 2 of 3
    NICOTINE TRANSDERMAL SYSTEM 
    nicotine transdermal system patch, extended release
    Product Information
    Item Code (Source)NDC:11822-1601
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1601-01 in 1 POUCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461209/15/2021
    Part 3 of 3
    NICOTINE TRANSDERMAL SYSTEM 
    nicotine transdermal system patch, extended release
    Product Information
    Item Code (Source)NDC:11822-1600
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE14 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1600-01 in 1 POUCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461209/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461209/15/2021
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Aveva Drug Delivery Systems (783982093)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveva Drug Delivery Systems Inc.783982093analysis(11822-1600, 11822-1601, 11822-1602, 11822-1603) , manufacture(11822-1600, 11822-1601, 11822-1602, 11822-1603)