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Since FDA first issued this consumer update in June 2023, FDA has approved Ycanth and issued a warning letter to companies selling unapproved products marketed for the treatment of molluscum. Published.
If you are suffering from skin sores, do not diagnose yourself or try to treat your symptoms with products that are not approved by the Food and Drug Administration. Instead, visit a medical professional for a proper diagnosis and treatment plan.
One common condition that some people try to self-diagnose and treat is molluscum contagiosum, a skin infection caused by a virus. But doing so risks delaying diagnosis and treatment of potentially more serious conditions. And you could do more harm than good.
There is only one FDA-approved treatment for molluscum, called Ycanth (cantharidin), and it must be administered by a medical professional. The FDA has not approved any nonprescription drug products to treat molluscum.
Symptoms and causes of molluscum
Molluscum, also known as water warts, is a common benign viral infection that causes white, pink, or flesh-colored bumps. These tumors can occur singly or in clusters almost anywhere on the skin, including the face, neck, arms, legs, abdomen, and genital areas. Bumps on the palms and soles of the feet are rare.
Sometimes the bumps may feel itchy or inflamed. Bumps may be larger or more numerous in people with weakened immune systems. Unless your symptoms are diagnosed by a medical professional, you won't know whether the bump is a molluscum or a symptom of another skin condition.
Molluscum is a common infection in children, but teens and adults can also get it. Molluscum can be transmitted by skin-to-skin contact, including sexual contact, and by sharing infected items such as clothing or sports equipment. Good hygiene (cleanliness) and avoiding direct contact with the bump are the best ways to prevent molluscum contamination. This includes washing your hands, keeping your hands, clothing, and equipment clean and covering any irregularities.
Molluscum will eventually resolve on its own without treatment, usually within 6 to 12 months, but in some cases it can take up to 5 years.
If you have molluscum, a dermatologist (dermatologist) or other health care professional can evaluate your symptoms and recommend ways to manage your symptoms.
Safe treatment of molluscs
The FDA has approved Ycanth (cantharidin) for the topical (on the skin) treatment of molluscum in adults and children over 2 years of age. Ycanth, the first molluscum treatment drug approved by the FDA, is administered to patients only by a medical professional. The health care provider will apply her Ycanth once every 3 weeks to the area of the patient's skin where the molluscum bump is located.
Do not sell non-prescription (over-the-counter or OTC) products that claim to treat molluscum, even if the company makes statements suggesting that their product has been reviewed or may be approved by the FDA. Do not purchase or use. Some companies claim that their products are “FDA approved,” “FDA registered,” manufactured in an “FDA registered facility,” or “comply with FDA's current good manufacturing practices” (or “CGMP”) may mislead consumers.
Unapproved products sold for the treatment of molluscum are likely not to be as effective as claimed, and their ingredients may cause harmful effects (adverse reactions). FDA has received reports of side effects in children and adults associated with some of these products, including skin redness, skin scratching abrasions, and permanent scarring.
Many unapproved products that claim to treat molluscum include essential oils. Even natural substances such as essential oils can cause allergic reactions or irritate sensitive skin.
