Eucrisa

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

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether crisaborole topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Crisaborole topical is not approved for use by anyone younger than 2 years old.

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Stinging.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Eucrisa is indicated for topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In an oral carcinogenicity study in Sprague-Dawley rats, oral doses of 30, 100, and 300 mg/kg/day crisaborole were administered to rats once daily. A drug-related increased incidence of benign granular cell tumors in the uterus with cervix or vagina (combined) was noted in 300 mg/kg/day crisaborole treated female rats (2 times the MRHD on an AUC comparison basis). The clinical relevance of this finding is unknown.

In a dermal carcinogenicity study in CD-1 mice, topical doses of 2%, 5% and 7% crisaborole ointment were administered once daily. No drug-related neoplastic findings were noted at topical doses up to 7% crisaborole ointment (2 times the MRHD on an AUC comparison basis).

Crisaborole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and human lymphocyte chromosomal aberration assay) and one in vivo genotoxicity test (rat micronucleus assay).

No effects on fertility were observed in male or female rats that were administered oral doses up to 600 mg/kg/day crisaborole (18 times the MRHD on an AUC comparison basis) prior to and during early pregnancy.

How Supplied

Eucrisa is a white to off-white ointment containing 2% crisaborole and is supplied in 60 g and 100 g laminate tubes.

60 g tube: NDC 55724-211-21
100 g tube: NDC 55724-211-11

Storage and Handling

Store at 20–25°C (68–77°F); excursions permitted to 15–30°C (59–86°F).
[see USP Controlled Room Temperature].

Keep tube tightly closed.

Physician SampleNot for Sale.
NDC 55724-211-42

Eucrisa™
(crisaborole) ointment, 2%

For Topical Use Only.
Not for ophthalmic, oral, or intravaginal use.

2.5 g
Rx ONLY

Physician SampleNot for Sale.
NDC 55724-211-23

Eucrisa™
(crisaborole) ointment, 2%

For Topical Use Only.
Not for ophthalmic, oral, or intravaginal use.

60 g
Rx ONLY

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.

Apply Eucrisa ointment as directed by yout healthcare provider. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, mouth, or vagina, rinse with water.

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.

Eucrisa ointment is usually applied twice daily. Follow your doctor's dosing instructions.

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

Applies to crisaborole topical: topical ointment

General

The most frequently reported side effect was application site pain.[Ref]

Local

Common (1% to 10%): Application site pain[Ref]

Dermatologic

Frequency not reported: Contact urticaria[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reaction[Ref]

Some side effects of Eucrisa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.