A head lice lotion that was initially approved by the FDA for prescription use will now be available over-the-counter.
The FDA approved Sklice lotion, with 0.5% ivermectin, for non-prescription use in patients 6 months and older after the company proved it was safe and effective when used as directed.
According to the Centers for Disease Control and Prevention (CDC), up to 12 million cases of head lice are reported in children ages 3 to 11 each year. They infect the head and neck area and attach their eggs to the base of the hair shaft. It’s most commonly spread by close person-to-person contact, as lice cannot hop or fly.
While they are found worldwide, in the U.S., it’s most common for an infestation to occur in children attending day care, elementary school and within the household of said children. Symptoms include tickling, or the feeling of something moving in the hair, along with itching, irritability and difficulty sleeping, and sores on the head caused by scratching.
“The Rx-to-OTC switch process aims to promote public health by increasing consumer access to drugs that would otherwise only be available by prescription,” Theresa Michele, M.D., acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said in a press release on Tuesday. “Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.
Sklice, which first earned FDA prescription approval in 2012, joins two other over-the-counter options for treating head lice. It’s a single-use lotion meant for topical treatment.