that contain a compound that can cause serious side effects and don't meet the requirements to be sold legally over-the-counter.are unapproved drugs and are not generally recognized as safe and effective, the FDA said in the April 13 letters.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration, also known as ochronosis. The discoloration can be permanent, the FDA says. The lighteners are marketed for use on age or dark spots on the skin associated with melasma. Melasma, sometimes called the ''mask of pregnancy," because it often happens then, is marked by light brown, dark brown or blue-gray patches on the skin., a prescription drug for the treatment of moderate to severe melasma of the face. It is meant to be used under the supervision of a health care professional.