FDA Approves First Retinoid Drug for Over-The-Counter (OTC) Use to Treat Acne - Drug Information Update
The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
Differin Gel 0.1% is the first in a class of drugs known as retinoids to be made available OTC for the treatment of acne, and contains the first new active ingredient for acne treatment for OTC use since the 1980s. Differin Gel 0.1% was originally approved in 1996 as a prescription product for the treatment of acne vulgaris in patients 12 years of age and older.
Women who are pregnant, planning to become pregnant, or breast-feeding should ask a doctor before use. While topical retinoid products are often prescribed as first-line therapies for acne of all levels of severity, either alone or in combination with other treatments, Differin Gel 0.1% is the first retinoid acne treatment to be made available OTC. While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans. Some other retinoid drugs have been shown to cause birth defects.
Consumers should follow the Drug Facts label and consult with their health care providers if their symptoms do not improve. The drug should be applied once daily in a thin layer on the affected areas of skin, and it is for external use only. Differin Gel 0.1% should not be used on damaged skin (for example, cuts, abrasions, eczema, or sunburn). People using Differin Gel 0.1% should avoid sunburn and avoid product contact with their eyes, lips and mouth. Differin Gel 0.1% should not be used by people who are allergic to the product. In the first few weeks of use, skin may become irritated (redness, itching, dryness, burning). Consumers should stop use and ask a doctor if irritation becomes severe, if there is no improvement in acne after three months of daily use, if symptoms of allergic reaction appear, or if they become pregnant or are planning to become pregnant while using the drug.
For more information, please visit: Differin Gel 0.1%.