NICOTINE PATCH [RUGBY LABORATORIES]

NICOTINE PATCH [RUGBY LABORATORIES]
PDF | XML

NDC 0536-5894-33, 0536-5894-53, 0536-5894-88, 0536-5895-33, 0536-5895-53, 0536-5895-71, 0536-5895-88, 0536-5896-33, 0536-5896-53, 0536-5896-71, 0536-5896-88
Set ID 2dd4cbda-5c46-4655-b69d-21b7d2e912cf
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number ANDA074612
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient Step One (in each patch)

    Nicotine, 21 mg delivered over 24 hours

  • Active ingredient Step Two (in each patch)

    Nicotine, 14 mg delivered over 24 hours

  • Active ingredient Step Three (in each patch)

    Nicotine, 7 mg delivered over 24 hours

  • Purpose

    Stop smoking aid

  • Uses

    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.

    Do not use

    • If you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use nicotine patch or other nicotine-containing products

    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.
    • 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 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 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 used patch 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
    • Stop smoking completely when you begin using the patch
    • If you smoke more than 10 cigarettes per day, use the following schedule:
     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 2 for 6 weeks, then Step 3 for 2 weeks and then stop
    • 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
    • Stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.
  • Other information

    Store at 20°-25°C (68°-77°F)

  • Inactive ingredients

    acrylate adhesive, polyester, silicone adhesive

  • Questions or comments?

    Call-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.

    For your family's protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn.

    • 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.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Step 1 – 21 mg Pouch Label

    Nicotine
    Transdermal
    System
    21 mg

    STEP
    ONE

    nicotine-transdermal-system-one-pouch.jpg
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Step 1 – 21 mg Carton Label

    Rugby®

    NDC 0536-5896-88

    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.

    nicotine-transdermal-system-one-carton.jpg
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Step 2 – 14 mg Pouch Label

    Nicotine
    Transdermal
    System
    14 mg

    STEP
    TWO

    nicotine-transdermal-system-two-pouch.jpg
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Step 2 – 14 mg Carton Label

    Rugby®

    NDC 0536-5895-88

    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.

    nicotine-transdermal-system-two-carton.jpg
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Step 3 – 7 mg Pouch Label

    Nicotine
    Transdermal
    System
    7 mg

    STEP
    THREE

    nicotine-transdermal-system-three-pouch.jpg
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Step 3 – 7 mg Carton Label

    Rugby®

    NDC 0536-5894-88

    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.

    nicotine-transdermal-system-three-carton.jpg
  • INGREDIENTS AND APPEARANCE
    NICOTINE 
    nicotine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5894
    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:0536-5894-537 in 1 CARTON10/20/1997
    1NDC:0536-5894-331 in 1 POUCH
    124 h in 1 PATCH; Type 0: Not a Combination Product
    2NDC:0536-5894-8814 in 1 CARTON10/20/1997
    2NDC:0536-5894-331 in 1 POUCH
    224 h in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461210/20/1997
    NICOTINE 
    nicotine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5895
    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:0536-5895-537 in 1 CARTON10/20/1997
    1NDC:0536-5895-331 in 1 POUCH
    124 h in 1 PATCH; Type 0: Not a Combination Product
    2NDC:0536-5895-8814 in 1 CARTON10/20/1997
    2NDC:0536-5895-331 in 1 POUCH
    224 h in 1 PATCH; Type 0: Not a Combination Product
    3NDC:0536-5895-7128 in 1 CARTON04/23/2019
    3NDC:0536-5895-331 in 1 POUCH
    324 h in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461210/20/1997
    NICOTINE 
    nicotine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-5896
    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:0536-5896-537 in 1 CARTON10/20/1997
    1NDC:0536-5896-331 in 1 POUCH
    124 h in 1 PATCH; Type 0: Not a Combination Product
    2NDC:0536-5896-8814 in 1 CARTON10/20/1997
    2NDC:0536-5896-331 in 1 POUCH
    224 h in 1 PATCH; Type 0: Not a Combination Product
    3NDC:0536-5896-7128 in 1 CARTON10/20/1997
    3NDC:0536-5896-331 in 1 POUCH
    324 h in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07461210/20/1997
    Labeler - Rugby Laboratories (079246066)
    Registrant - Aveva Drug Delivery Systems, Inc (783982093)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveva Drug Delivery Systems, Inc783982093manufacture(0536-5894, 0536-5895, 0536-5896)
    Establishment
    NameAddressID/FEIBusiness Operations
    Siegfried AG482824026api manufacture(0536-5894, 0536-5895, 0536-5896)