Crisaborole topical (for use on the skin) is used to treat mild to moderate eczema (atopic dermatitis) in adults and children who are at least 3 months old.

Crisaborole topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Avoid getting crisaborole topical in your eyes, mouth, or vagina.

Rinse with water if this medicine gets in your eyes or mouth.

Do not share this medicine with another person, even if they have the same symptoms you have.

Apply a thin layer to the affected skin.

Wash your hands after applying this medicine, unless you are using it to treat eczema on your hands.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Store at room temperature away from moisture and heat. Keep the tube tightly closed when not in use.

Usual Adult Dose for Atopic Dermatitis:

Apply a thin layer to the affected area(s) twice a day

Use: For the topical treatment of mild to moderate atopic dermatitis

Usual Pediatric Dose for Atopic Dermatitis:

2 years or older: Apply a thin layer to the affected area(s) twice a day

Use: For the topical treatment of mild to moderate atopic dermatitis

You should not use crisaborole topical if you are allergic to it.

Tell your doctor if you are pregnant or breastfeeding.

Crisaborole topical is not approved for use by anyone younger than 3 months old.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

An overdose of crisaborole topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Keep this medication in the tube it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, skin redness or swelling; difficult breathing; swelling of your face, lips, tongue, or throat.

crisaborole topical may cause serious side effects. Stop using crisaborole topical and call your doctor at once if you have:

• severe itching, redness, or swelling of the skin where the medicine was applied.

Common side effects of crisaborole topical may include:

• pain, burning, or stinging where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.