Label: NIENJOY NICOTINE TRANSDERMAL SYSTEM- nienjoy nicotine transdermal system patch patch

  • NDC Code(s): 84318-001-01
  • Packager: Hangzhou Fanhuo Network Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 15, 2024

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

  • ACTIVE INGREDIENT

    Nicotine, 21 mg delivered over 24 hours.

  • PURPOSE

    Stop smoking aid

  • INDICATIONS & USAGE

    Reduces withdrawral symptoms, including nicotine craving.associated with quiting smoking.

  • WARNINGS

    If you are breast-feeding or pregnant,you should not use nicotine patches in any form asit may have adverse effects onyour baby's development. Try to stopsmoking without using any nicotine replacement medicine.This medicine is believed to be safer than smoking. However,the risks to your child from this medicine arenot fully known.

  • DO NOT USE

    Ask a doctor or pharmacist before use if you are

    Use non-nicotine smoking cessation medications

    Take prescription medications for depression or asthma.

    Less than 18 years old.

  • WHEN USING

    When using this product if you have vivid dreams or other sleep disturbances remove this patch at bedtime

  • STOP USE

    Stop use and ask a doctor if

    Aheart attack in the last two weeks.

    A serious heart rhythm problem.

    Pain in your heart (angina) that is serious or getting worse.

    Alergy to adhesive tape or other serious skin problemslike psoriasis and eczema.

    High blood pressure not controlled with medication.Nicotine can increaseblood pressure

    Stomach ulcer or diabetes

    Ahistory of seizures

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and petsUsed patches contain enough nicotine to poison children and pets. If swallowed, get medical help or contact a poison control center immediately and save bag for patch disposal. Dispose of used patches by folding the sticky ends together and placing in a bag

  • DOSAGE & ADMINISTRATION

    Directions

    -If youare under 18 years of age,ask a doctor before use.

    -Start using the patch on quit day.

    -Because the different types of cigarettes that each person smokes, thenicotine content of each type of cigarette varies, and the amount absorbed by thehuman body also varies. Therefore, if you smoke 10 or fewer cigarettes per day,stick between 0.5and 1.5 patches each time. Ifyou smoke more than 10 cigarettes per day, stick between 1 and 5 patches each time. Before using this product, carefully read the product instructions inside the packaging for a complete list of usage quantities.

    -Apply anewpatch to dry, dlean, hair-free skin every24 hours.

    -Remove backing from patch and press immediately to skin.hold for 10 seconds.

    -Wash your hands after applying or removing the patch.Save pouch to use for patch disposal.

    - Dispose of used patches by folding them together and placing them in a bag.

    -Used patches should be removed and new patches applied to a diflerent area of skin at the same time each day

    - If you havevivid dreams, you may remove the patch at bedtime and apply a new one in themorning.

    - Do not leave the patch on for more than 24 hours as it may irritate your skin and losestrength after 24 hours

    -It is important to complete treatment and talk to your healthcare provider if you feel you need to use the patch longer to quit smoking.

  • STORAGE AND HANDLING

    Store at 20-25℃(68-77°F)

    Detailed product instructions included in the package

  • INACTIVE INGREDIENT

    acrylate copolymer,polypropylene,polyethylene terephthalate

  • PRINCIPAL DISPLAY PANEL

    84318-001-01

  • INGREDIENTS AND APPEARANCE
    NIENJOY NICOTINE TRANSDERMAL SYSTEM 
    nienjoy nicotine transdermal system patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84318-001
    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
    POLYPROPYLENE (30000 MW) (UNII: T71QXI2O62)  
    POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.40-0.70) (UNII: Y78AJD3DED)  
    METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84318-001-017 in 1 BOX05/10/2024
    124 h in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02007605/10/2024
    Labeler - Hangzhou Fanhuo Network Technology Co., Ltd. (713800244)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Fanhuo Network Technology Co., Ltd.713800244manufacture(84318-001)