Eucrisa®(crisaborole)

EUCRISA is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis) in adults and children 3 months of age and older.

It is not known if EUCRISA is safe and effective in children under 3 months of age.

• are allergic to crisaborole or any of the ingredients in EUCRISA. See the end of this leaflet for a complete list of ingredients in EUCRISA.

• are pregnant or plan to become pregnant. It is not known if EUCRISA will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if EUCRISA passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Use EUCRISA exactly as your healthcare provider tells you to use it.
• Apply a thin layer of EUCRISA to the affected areas 2 times a day.
• Wash your hands after applying EUCRISA, unless you are treating your hands.
• If a caregiver applies EUCRISA, the caregiver should wash their hands after application.

EUCRISA may cause serious side effects, including:

• Allergic reactions. Stop using EUCRISA and get medical help right away if you have any of the following symptoms:

◦ trouble breathing or swallowing

◦ swelling of the face, lips, tongue, or throat

◦ hives

◦ severe itching

◦ faintness or dizziness

◦ chest tightness

The most common side effect of EUCRISA is:

• application site pain, such as burning or stinging

These are not all the possible side effects of EUCRISA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store EUCRISA at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the tube tightly closed.
• Keep EUCRISA and all medicines out of the reach of children.

Active ingredient: crisaborole

Inactive ingredients: white petrolatum, propylene glycol, mono- and di-glycerides, paraffin, butylated hydroxytoluene, and edetate calcium disodium