FDA Approves Sklice (ivermectin) lotion for OTC Use to Treat
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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.

Rx-to-OTC switches are generally initiated by the manufacturer of the prescription drug. For a drug to switch from prescription to nonprescription status, the data provided must demonstrate that the drug is safe and effective when used as directed in the proposed labeling.

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, and its active ingredient ivermectin, have not been shown to be safe or effective for the treatment or prevention of COVID-19 and they are not FDA-approved for this use.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-lotion-nonprescription-use-treat-head-lice
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