US FDA approved Daphne (0.1%) as an over-the-counter drug for acne (acne)

In July 8, 2016, the US Food and Drug Administration approved OTC (Duff) (0.1%) (Adapalene Gel) for acne vulgaris, aged 12 and over, once daily for external use Daphne (0.1%) is the first over-the-counter drug for external use of retinoids to treat acne In the 1980s, Daphne was used as the first new active ingredient to treat acne Daphne (0.1%) was initially approved in 1996 as a prescription drug for acne treatment in patients over 12 years of age "Millions of consumers, from teenagers to adults, have acne, and now patients have the right to a new safe and effective over-the-counter option," said Lesley Furlong, deputy director of the office of new drug division 4, FDA's Center for drug evaluation and research Acne is a common skin disease that affects about 50 million people in the United States The formation of acne (acne) is a blockage in the hair follicles of the skin In general, acne occurs on the face, neck, back, chest and shoulders Anyone can get acne, which is most common in teenagers Acne can cause scarring and have adverse psychological effects (for example, poor self-image, depression and anxiety) Some over-the-counter drugs and prescription treatment programs can be used to treat acne patients Pregnant women, women planning to be pregnant or breastfeeding should consult a doctor before use At the same time, external retinoic acid products are often prescribed as the first-line treatment drugs for severe acne at all levels, alone or in combination with other treatment methods Daphne (0.1%) is the first OTC drug for retinoic acid treatment of acne Although there is not enough and good maternal control study of Duff (0.1%), there is no specific evidence that Duff (0.1%) can lead to birth defects when used locally Other retinoids have been shown to cause birth defects The safety and efficacy of Daphne (0.1%) were initially established in five mild to moderate acne clinical trials In order to support OTC marketing approval to submit the following data, the data comes from 1996-2016 post market security, from consumer research data (tag understanding learning, self selected research and actual use test), and from maximum use test data In general, the research results from consumers show that consumers can understand the information on the labels of over-the-counter drugs, properly select whether the products are suitable for them, and properly use the products During the maximum use of test drug, daily application of acne skin in large-area absorption study (face, shoulder, back and chest) shows that absorption is limited, so it supports the safe use of Daphne (0.1%) as OTC drug If their symptoms do not improve, consumers should check the drug label and have a health care consultation The drug is applied once a day to acne areas of the skin and is intended for external use only Daphne (0.1%) should not be used for damaged skin (e.g., cuts, abrasions, eczema, or sunburn) People using Daphne (0.1%) should avoid sunburn and contact with eyes, lips and mouth Patients allergic to Daphne (0.1%) should not use it During the first few weeks of use, the skin may become irritating (red, itchy, dry, blazing) In the following cases, acne patients should stop using and ask the doctor, the stimulation becomes serious, there is no improvement after three months of daily use, there are symptoms of allergic reaction, or pregnancy or planned pregnancy.