Sklice Goes Over-the-Counter

Sklice (ivermectin) lotion, 0.5% is now approved for OTC sale. Sklice (Arbor Pharmaceuticals) was originally FDA approved as a prescription treatment for head lice infestation in patients six months of age and older in February 2012.

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

Sklice is a single-use lotion with ivermectin 0.5% as the active ingredient, for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice is for external use only and should only be used on the scalp and dry hair in accordance with label directions. Sklice is not approved for any other use.

Sklice will be marketed in the United States as a nonprescription drug and will no longer be available as a prescription drug.