EPIDUO (adapalene and benzoyle peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%.

Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula:

Adapalene:

Molecular formula: C₂₈H₂₈O₃      Molecular weight: 412.5

Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes.

The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula:

Benzoyl Peroxide:

Molecular formula: C₁₄H₁₀O₄      Molecular weight: 242.23     

EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate.

SIDE EFFECTS: Skin redness, dryness, peeling, mild burning, swelling, or worsening of acne may occur during the first 4 weeks of using this product. These effects usually decrease with continued use. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Your doctor may want you to use a moisturizer, decrease how often you use the product, or have you stop using it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to adapalene or benzoyl peroxide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other skin conditions (such as eczema).

This drug may bleach hair or colored fabric (such as clothing, bedding, and towels). Use caution when applying near the hairline, while dressing, and while choosing towel and bed sheet colors (if leaving on the skin overnight).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear a hat or other protective clothing when outdoors. Wait until your skin has completely recovered from a sunburn before using this product. Weather extremes such as wind or cold may also be irritating to the skin.

Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when used on the skin. Consult your doctor before breast-feeding.