Clascoterone topical is used to treat acne vulgaris in people who are at least 12 years old.

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

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

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

Do not take by mouth. Topical medicine is for use only on the skin.

Wash your hands before and after applying clascoterone topical. Use a mild soap to clean the skin area to be treated.

Dry the skin thoroughly before applying clascoterone topical.

Use only a small amount of medicine. Apply a thin layer and rub in gently.

Clascoterone topical is usually applied twice per day, morning and evening. Follow your doctor's dosing instructions very carefully.

Do not cover treated skin with a bandage unless your doctor tells you to.

Store tightly closed at room temperature away from moisture and heat. Do not freeze.

Throw away any unused clascoterone cream 1 month after you first opened the tube or 180 days after you received this medicine from the pharmacy (whichever comes first).

Usual Adult Dose for Acne:

Apply a thin uniform layer, approximately 1 gram twice per day, in the morning and the evening.

Comment: For topical use only. Not for ophthalmic, oral, or vaginal use.

Use: For the topical treatment of acne vulgaris in patients 12 years of age and older

Usual Pediatric Dose for Acne:

12 years or older: Apply a thin uniform layer, approximately 1 gram twice per day, in the morning and the evening.

Comments:
-Pediatric patients may be more susceptible to systemic toxicity.
-For topical use only. Not for ophthalmic, oral, or vaginal use.

Use: For the topical treatment of acne vulgaris in patients 12 years of age and older

Tell your doctor if you have ever had eczema or other skin problems.

Tell your doctor if you are pregnant or breastfeeding.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

Avoid applying clascoterone topical to open wounds, areas of eczema, or on sunburned or irritated skin.

Avoid getting this medicine in your eyes, mouth, nose, vagina, or rectum. Rinse with water if this occurs.

Avoid using harsh soaps, scrubbing cleansers, or any cosmetics or other skin products that can cause dryness or irritation. Avoid using skin products that contain alcohol, astringents, or lime.

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

Clascoterone topical may cause serious side effects. Call your doctor at once if you have:

• severe itching, burning, peeling, or redness of treated skin;

• high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or

• decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

Serious side effects may be more likely to occur in younger people.

Common side effects of clascoterone topical may include:

• redness, itching, stinging, burning, or swelling of treated skin; or

• dry or scaly skin.

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.

Medicine used on the skin is not likely to be affected by other drugs you use, but many drugs can interact. Tell your doctor about all your current medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.