r skin. If you need to be outdoors after applying PROTOPIC Ointment, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use.
Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing.
Avoid getting PROTOPIC Ointment in the eyes or mouth. Do not swallow PROTOPIC Ointment. If you do, call your doctor.
What are the possible side effects of PROTOPIC Ointment?
Please read the first section of this Medication Guide.
The most common side effects of PROTOPIC Ointment at the skin application site are stinging, burning, or itching of the skin treated with PROTOPIC. These side effects are usually mild to moderate, are most common during the first few days of treatment, and usually go away as your skin heals.
Other side effects include acne, swollen or infected hair follicles, headache, increased sensitivity of the skin to hot or cold temperatures, or flu-like symptoms such as the common cold and stuffy nose, skin tingling, upset stomach, muscle pain, swollen glands (enlarged lymph nodes), or skin infections including cold sores, chicken pox or shingles.
Talk to your doctor if you have a skin infection or if side effects (for example, swollen glands) continue or bother you.
While you are using PROTOPIC, drinking alcohol may cause the skin or face to become flushed or red and feel hot.
These are not all the side effects with PROTOPIC Ointment. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
How should I store PROTOPIC Ointment?
Store PROTOPIC Ointment at room temperature (59° to 86°F). Do not leave PROTOPIC Ointment in your car in cold or hot weather. Make sure the cap on the tube is tightly closed.
Keep PROTOPIC Ointment and all medicines out of the reach of children.
General advice about PROTOPIC Ointment
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROTOPIC Ointment for a condition for which it was not prescribed. Do not give PROTOPIC Ointment to other people, even if they have the same symptoms you have. It may not be right for them.
This Medication Guide summarizes the most important information about PROTOPIC Ointment. If you would like more information, talk with your doctor.
Your doctor or pharmacist can give you information about PROTOPIC Ointment that is written for health care professionals. For more information, you can also visit the PROTOPIC website at www.protopic.com or call 1-800-727-7003.
What are the ingredients in PROTOPIC Ointment?
Active Ingredient: tacrolimus, either 0.03% or 0.1%
Inactive Ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum and white wax.
Marketed by:
Astellas Pharma US, Inc.
Deerfield, IL 60015-2548
Manufactured by:
Astellas Toyama Co., Ltd. Toyama Plant, 2-178 Kojin-machi, Toyama 930-0809, Japan
This Medication Guide has been approved by the U.S. Food and Drug Administration
Revised: June 2009
09F001-PRT-CPI
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30g 0.03% Individual Carton
30g 0.03% Individual Carton
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30g 0.1% Individual Carton
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2g 0.03% Accumulated Carton
2g 0.03% Accumulated Carton
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