Label: NICOTINE patch
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Contains inactivated NDC Code(s)
NDC Code(s): 58118-9842-1, 58118-9842-4 - Packager: Clinical Solutions Wholesale
- This is a repackaged label.
- Source NDC Code(s): 0536-5896
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 1, 2013
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 (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.
Do not use
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- 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
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- Heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
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- High blood pressure not controlled with medication. Nicotine can increase your blood pressure.
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- 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
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- Using a non-nicotine stop smoking drug
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- Taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.
When using this product
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- 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.
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- If you have vivid dreams or other sleep disturbances, remove this patch at bedtime
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Directions
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- If you are under 18 years of age, ask a doctor before use
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- Before using this product, read the enclosed self-help guide for complete directions and other information
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- Stop smoking completely when you begin using the patch
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- 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
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- 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
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- Apply one new patch every 24 hours on skin that is dry, clean, and hairless
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- Remove backing from patch and immediately press onto skin. Hold for 10 seconds.
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- 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.
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- The used patch should be removed and a new one applied to a different skin site at the same time each day
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- If you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
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- Do not wear more than one patch at a time
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- Do not cut patch in half or into smaller pieces
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- Do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
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- 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
- Inactive ingredients
- Comments or questions?
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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
Free Audio CD upon request.
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:58118-9842(NDC:0536-5896) 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:58118-9842-4 14 in 1 CARTON 1 NDC:58118-9842-1 1 in 1 POUCH 1 24 h in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074612 10/20/1997 Labeler - Clinical Solutions Wholesale (078710347) Registrant - Clinical Solutions Wholesale (078710347) Establishment Name Address ID/FEI Business Operations Clinical Solutions Wholesale 078710347 RELABEL(58118-9842)
