FDA approves Sklice for OTC use

The US Food and Drug Administration (FDA) has approved Sklice (ivermectin) lotion, 0.5% for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch.¹ It was initially approved as a prescription drug for the treatment of head lice infestation in patents aged 6 months and older in February 2012.

Sklice contains ivermectin 0.5% as the active ingredient and is a single-use lotion. It is meant for the topical treatment of a head lice infestation. It is meant only for external use and should only be applied to the scalp and dry hair, which is noted on the label directions. It is not approved for any other use. For patients who currently have a prescription version of Sklice, they should reach out to their health care provider for guidance.

In a press release for the approval Theresa Michele, MD, acting director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research said, “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. Today’s approval expands access to another effective topical treatment for the thousands of people with head lice.”

Reference

1. US Food and Drug Administration. FDA approves lotion for nonprescription use to treat head lice. US Food and Drug Administration. Published October 27, 2020. Accessed October 28, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-lotion-nonprescription-use-treat-head-lice​