Adapalene is a medicine similar to vitamin A. It helps the skin renew itself.

Adapalene topical (for use on the skin) is used to treat severe acne in people who are at least 12 years old.

Adapalene 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.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or for longer than recommended. Using adapalene topical in larger amounts than recommended will not make it work faster, and may cause unpleasant side effects.

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

Adapalene topical is usually applied once daily in the evening.

Wash your hands before applying this medicine.

Clean your skin with a mild non-medicated skin cleanser before applying the medicine. Pat the skin dry with a clean towel.

Apply a thin layer to the entire face or other affected skin areas. Avoid applying the medicine to the creases of your nose, or on your lips.

Do not apply to open wounds or on sunburned, windburned, dry, chapped, or irritated skin. Do not apply any other skin products unless your doctor has told you to.

Avoid getting this medicine in your eyes, nose, or mouth.

You may use a skin moisturizer if your skin becomes dry while using adapalene. Avoid creams or lotions that contain alpha hydroxy or glycolic acids.

It may take several weeks before your acne improves, and it may get slightly worse for a short time when you first start using adapalene. Keep using the medication as directed, even if you think it is not working.

Call your doctor if skin symptoms do not begin to improve within 8 to 12 weeks of using this medicine.

Do not use adapalene topical to treat any condition that has not been checked by your doctor.

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

Usual Adult Dose for Acne:

Usual dose: Apply a thin layer to the affected area once a day at bedtime

Comments:
-The affected area should be thoroughly washed and dried before application.
-Patients may experience a transient warming sensation after application of the cream formulation.
-An apparent exacerbation of acne may occur during the first weeks of treatment, and should not be a reason to discontinue treatment.

Use: Topical treatment of acne vulgaris

Usual Pediatric Dose for Acne:

12 years and older:
-Usual dose: Apply a thin layer to the affected area once a day at bedtime

Comments:
-The affected area should be thoroughly washed and dried before application.
-Patients may experience a transient warming or stinging sensation after application of the cream formulation.
-An apparent exacerbation of acne may occur during the first weeks of treatment, and should not be a reason to discontinue treatment.

Use: Topical treatment of acne vulgaris

You should not use adapalene topical if you are allergic to adapalene.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions.

It is not known whether adapalene passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

It is not known whether adapalene will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

Adapalene is not approved for use by anyone younger than 12 years old.

Apply the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not apply extra medicine to make up the missed dose.

Seek emergency medical attention if you think you have used too much of adapalene topical. Overdose symptoms may include skin redness, scaling, or irritation.

Avoid exposure to sunlight or tanning beds. Adapalene can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using other skin medications that contain sulfur, resorcinol, or salicylic acid (common in topical acne medications or skin cleansers).

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

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

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

• skin redness, stinging, burning, or peeling after sun exposure.

Some side effects may occur during the first 4 weeks of using this medicine. These side effects should become less noticeable with continued use.

Common side effects of adapalene topical may include:

• dry, red, or scaly skin;

• feeling of warmth and mild stinging or burning;

• peeling skin; or

• skin pain.

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.

It is not likely that other drugs you take orally or inject will have an effect on topically applied adapalene. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.