FDA Approves Rx-to-OTC Switch of Sklice for Head Lice Treatment

The Food and Drug Administration (FDA) has approved a prescription to over-the-counter (OTC) switch for Sklice (ivermectin lotion 0.5%; Arbor Pharmaceuticals), a pediculicide indicated for the treatment of head lice infestation in patients aged 6 months and older.

The OTC formulation of Sklice will be supplied in a single-use 117g tube; each gram of lotion contains 5mg of ivermectin, the same as the prescription strength. The product is for topical use only and should be used in the context of an overall lice management program. Sklice will no longer be available as a prescription drug.

“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,” said 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.”

For more information visit fda.gov.

References

1. FDA approves lotion for nonprescription use to treat head lice. [press release]. Silver Spring, MD: US Food and Drug Administration; October 27, 2020. 
2. Sklice [package insert]. Atlanta, GA: Arbor Pharmaceuticals; 2020.