ELIDEL- pimecrolimus cream
Bausch Health US, LLC
Important: ELIDEL Cream, 1% is for use on the skin only (topical). Do not get ELIDEL Cream, 1% in your eyes, nose, mouth, vagina, or rectum.
What is the most important information I should know about ELIDEL Cream, 1%?
It is not known if ELIDEL Cream, 1% is safe to use for a long period of time. A very small number of people who have used ELIDEL Cream, 1% have developed cancer (for example, skin cancer or lymphoma). But a link that ELIDEL Cream, 1% use caused these cancers has not been shown. Because of this concern:
What is ELIDEL Cream, 1%?
ELIDEL Cream, 1% is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis). ELIDEL Cream, 1% is for adults and children age 2 years and older who do not have a weakened immune system. ELIDEL Cream, 1% is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL Cream, 1% is for use after other prescription medicines have not worked for you or if your doctor recommends that other prescription medicines should not be used.
It is not known if ELIDEL Cream, 1% is safe and effective in people who have a weakened immune system.
ELIDEL Cream, 1% is not for use in children under 2 years of age.
Who should not use ELIDEL Cream, 1%?
Do not use ELIDEL Cream, 1% if you are allergic to pimecrolimus or any of the ingredients in ELIDEL Cream, 1%. See the end of this Medication Guide for a complete list of ingredients in ELIDEL Cream, 1%.
What should I tell my doctor before using ELIDEL Cream, 1%?
Before using ELIDEL Cream, 1%, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor about all the skin medicines and products you use.
Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.
How should I use ELIDEL Cream, 1%?
What should I avoid while using ELIDEL Cream, 1%?
What are the possible side effects of ELIDEL Cream, 1%?
ELIDEL Cream, 1% may cause serious side effects.
Other common side effects include:
Tell your doctor if you get a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away.
These are not all the possible side effects with ELIDEL Cream, 1%. 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 ELIDEL Cream, 1%?
Keep ELIDEL Cream, 1% and all medicines out of the reach of children.
General information about the safe and effective use of ELIDEL Cream, 1%
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ELIDEL Cream, 1% for conditions other than which it was prescribed. Do not give ELIDEL Cream, 1% to other people even if they have the same symptoms you have. It may harm them.
You can ask your doctor or pharmacist for information about ELIDEL Cream, 1% that is written for health professionals.
For more information, call 1-800-321-4576.
What are the ingredients in ELIDEL Cream, 1%?
Active ingredient: pimecrolimus
Inactive ingredients: benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada
Produced under license from MEDA
PHARMA S.A.R.L., Luxembourg,
by Bausch Health US, LLC.
ELIDEL is a trademark of MEDA PHARMA
S.A.R.L. used under license.
© 2020 Bausch Health Companies Inc.
or its affiliates
Rev. 09/2020 9462405