FDA Approves Lotion for Nonprescription Use to Treat Head Lice
Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice (ivermectin) lotion, 0.5% for the treatment of head lice infestation in patients 6 months of age and older as a prescription drug in February 2012.
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. Consumers should read and follow the Drug Facts label for the nonprescription product. Patients who currently use prescription versions of this product should talk to their healthcare professional.
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