PIMECROLIMUS- pimecrolimus cream 
REMEDYREPACK INC.

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MEDICATION GUIDE
Pimecrolimus (pimʺ e kroeʹ li mus) Cream, 1%

Important: Pimecrolimus cream, 1% is for use on the skin only (topical). Do not get pimecrolimus cream, 1% in your eyes, nose, mouth, vagina, or rectum.

What is the most important information I should know about pimecrolimus cream, 1%?

It is not known if pimecrolimus cream, 1% is safe to use for a long period of time. A very small number of people who have used pimecrolimus cream, 1% have developed cancer (for example, skin cancer or lymphoma). But a link that pimecrolimus cream, 1% use caused these cancers has not been shown. Because of this concern:

What is pimecrolimus cream, 1%?

Pimecrolimus cream, 1% is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis). Pimecrolimus cream, 1% is for adults and children age 2 years and older who do not have a weakened immune system. Pimecrolimus cream, 1% is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. Pimecrolimus 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 pimecrolimus cream, 1% is safe and effective in people who have a weakened immune system.

Pimecrolimus cream, 1% is not for use in children under 2 years of age.

Who should not use pimecrolimus cream, 1%?

Do not use pimecrolimus cream, 1% if you are allergic to pimecrolimus or any of the ingredients in pimecrolimus cream, 1%. See the end of this Medication Guide for a complete list of ingredients in pimecrolimus cream, 1%.

What should I tell my doctor before using pimecrolimus cream, 1%?

Before using pimecrolimus 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 pimecrolimus cream, 1%?

What should I avoid while using pimecrolimus cream, 1%?

What are the possible side effects of pimecrolimus cream, 1%?

Pimecrolimus 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 pimecrolimus 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 pimecrolimus cream, 1%?

Keep pimecrolimus cream, 1% and all medicines out of the reach of children.

General information about the safe and effective use of pimecrolimus cream, 1%

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pimecrolimus cream, 1% for conditions other than which it was prescribed. Do not give pimecrolimus 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 pimecrolimus cream, 1% that is written for health professionals.

For more information call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.

What are the ingredients in pimecrolimus cream, 1%?

Active ingredient: pimecrolimus

Inactive ingredients: benzyl alcohol, cetyl alcohol, cetostearyl alcohol (type A), citric acid anhydrous, medium-chain triglycerides, mono- and di-glycerides, oleyl alcohol, propylene glycol, sodium hydroxide, stearyl alcohol, and water.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Iss. 5/2018

Revised: 9/2019
REMEDYREPACK INC.