FDA Label for Nicotine Transdermal System
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH PATCH)
- PURPOSE
- USE
- IF YOU ARE PREGNANT OR BREAST-FEEDING, ONLY USE THIS MEDICINE ON THE ADVICE OF YOUR HEALTH CARE PROVIDER.
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN AND PETS.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Nicotine Transdermal System Product Label
The following document was submitted to the FDA by the labeler of this product Sam's West Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Patch)
Nicotine, 21 mg delivered over 24 hours
Purpose
Stop smoking aid
Use
reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
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, or use a nicotine gum 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 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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.
Directions
• if you are under 18 years of age, ask a doctor before use• before using this product, read the enclosed User’s 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 according to the following 10 week schedule:• if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg), for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop.• steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.• apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.• remove backing from patch and immediately press onto skin. Hold for 10 seconds.• wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling.• you may wear the patch for 16 or 24 hours• if you crave cigarettes when you wake up, wear the patch for 24 hours• if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning• the used patch should be removed and a new one applied to a different skin site at the same time each day• 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 10 weeks. If you started with STEP 2, 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
ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings
Questions Or Comments?
call toll-free 1-866-255-5205 (English/Spanish) weekdays
TO INCREASE YOUR SUCCESS IN QUITTING:
• You must be motivated to quit.• Complete the full treatment program, applying a new patch every day.• Use with a support program as described in the enclosed User’s Guide.• Not for sale to those under 18 years of age.• Prrof of age required.• Not for sale in vending machines or from any source where proof of age cannot be verified.
Principal Display Panel
NDC 68196-194-03
nicotine patch
Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid
21 mg
SIMPLY RIGHT™
Health Care
Compare to NicoDerm®CQ®*
Includes behavior support program enrollment form & user’s guide
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
step 1
21 clear patches
©2011
101775XA
* Please review the disclaimer below.