FDA approves over-the-counter head lice lotion

The U.S. Food and Drug Administration (FDA) approved the over-the-counter (OTC) use of a lotion designed to treat head lice. 

Previously available through prescription, the FDA has put the treatment through a process called prescription-to-OTC switch, according to an FDA news release. The lotion is named Sklice, and it was originally approved in 2012 for use with a prescription. 

“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," the news release stated.

The switchover process is typically begun by the manufacturer of the drug requesting a review and switch. The goal of this process is to ensure that consumers have increased access to helpful drugs, but it's important to protect patients from drugs with adverse or severe side effects, as well. For that reason, the FDA requires that data is presented that proves that the drug is completely safe and does what it advertises itself to do when used correctly and according to directions. In addition, the manufacturer of the drug must demonstrate that consumers will know how to correctly use the drug without causing themselves or others harm. 

Lice is a common issue that sees up to 12 million cases annually and mostly affects children between the ages of three and 11. As a prominent issue in the country, getting effective products that are safe to the over-the-counter market is a plus for the average consumer. As a result of its change in status to an over-the-counter drug, Sklice will no longer be available for prescription and instead must be purchased OTC. 

The FDA has issued the approval to Arbor Pharmaceuticals LLC for treatment in patients six months of age or older.