Adapalene, Benzoyl Peroxide Topical gel

What is this medicine?

ADAPALENE; BENZOYL PEROXIDE (a DAP a leen; BEN zoe ill per OX ide) is used on the skin to treat acne.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• eczema

• seborrheic dermatitis

• skin abrasions

• sunburn

• an unusual or allergic reaction to adapalene, benzoyl peroxide, vitamin A, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions on the prescription label. Cleanse the affected area with a mild or soapless cleanser and pat dry. Apply a thin layer of medicine to the affected area. Rub in gently. Do not get in the eyes, on the lips, or on any other areas of sensitive skin. Use your medicine at regular intervals. Do not use it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

• other acne medicines

• salicylic acid or sulfur containing products

• topical antibiotics like clindamycin or erythromycin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your acne may get worse at first, and then should start to get better. It may take 2 to 12 weeks before you see the full effect.

Do not use products that may dry the skin like medicated cosmetics, products that contain alcohol, astringents, spices, limes, or abrasive soaps or cleaners. Do not use other acne or skin treatments on the same area that you use this medicine unless your doctor or health care professional tells you to. If you use these together they can cause severe skin irritation.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

This medicine may bleach hair or colored fabrics. Avoid getting the medicine on your clothes.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• severe burning, redness, crusting, or swelling of the treated areas

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• increased sensitivity to the sun

• inflamed, stinging, and irritated skin

• skin that peels after a few days of use

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medication after the expiration date.