WASHINGTON -- The FDA approved adapalene gel 0.1% (Differin), a retinoid used in the treatment of acne, for over-the-counter use in persons 12 years of age and older.

This was the first time that a retinoid has been approved for over-the-counter use in acne treatment. Differin gel (distributed by Galderma Laboratories) is also notable for containing the first new active ingredient in the treatment of acne to be made available over-the-counter since the 1980s.

"Millions of consumers, from adolescents to adults, suffer from acne," said Lesley Furlong, MD, of the FDA's Center for Drug Evaluation and Research in a statement. "Now, consumers have access to a new safe and effective over-the-counter option."

Adapalene was first approved in 1996 as a prescription treatment for acne, and the American Acne and Rosacea Society had previously stated that the drug was safe to use in adolescent patients ages 12 and older.

In April, the FDA's Nonprescription Drugs Advisory Committee recommended the OTC approval by a 16-0 vote. Post-marketing studies presented to the committee showed that consumers can understand the product label, determine whether the product is right for them, and use the product appropriately. In addition, a study of absorption of the drug through acne-affected skin when applied daily over a large surface area (face, shoulders, upper back, and chest), showed that absorption is limited even with maximal use.

The drug label contains a warning for women who are pregnant, planning to become pregnant, or who are breastfeeding to consult their doctor prior to use of the treatment. While no adequate and well-controlled studies exist on the link between the specific use of adapalene and birth defects, other retinoid drugs have been shown to cause birth defects.

The product is to be applied once daily, and should avoid being applied to sunburned skin. Patients should consult with a physician if any of the following apply:

Symptoms do not improve

Irritation becomes severe

No improvement after 3 months of use

The patient has an allergic reaction to the drug

In addition, patients who become pregnant or planning a pregnancy while using the drug should consult their provider immediately.