Common Lice Treatment Approved as OTC

FDA approves switch of Sklice (ivermectin) from Rx to OTC

(RxWiki News) The US Food and Drug Administration (FDA) has approved a common lice treatment to be available over-the-counter (OTC).

This medication is found under the names Sklice (brand) and ivermectin (active ingredient).

Available as a lotion, it can now be found OTC. That means this particular medication no longer needs a prescription from a doctor.

Sklice (ivermectin) lotion, 0.5%, was initially approved in February 2012 as a treatment for head lice in children starting as young as 6 months old.

"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 Dr. Theresa Michele, acting director of the FDA's Office of Nonprescription Drugs, in a press release.

For the minimum of 6 million lice cases the US sees each year, this new approval offers a treatment that can be accessed faster and more easily.

For the switch to OTC to happen, the drugmaker must show that the medication is both safe and effective when consumers follow the included directions. The company must show that consumers understand the instructions on how to use the medication both for safety and efficacy reasons without the supervision of a health care provider.

The indication for ivermectin lotion stays the same: This lotion is approved to treat head lice infestations in patients 6 months of age and older.

This external-use-only medication is only to be applied to the scalp and dry hair. This medication, in lotion form, is not approved to treat any other conditions.

Some common side effects may include dandruff, dry skin and a burning sensation of the skin.

Now that ivermectin lotion has made the switch to OTC, it will no longer be available by prescription, the FDA noted.

Always read the Drug Facts label of OTC products. This is typically found on the back or side of the product. Talk to your pharmacist if you have any questions about this treatment.

The FDA noted that Sklice (ivermectin) was not FDA-approved to treat or prevent COVID-19. This medication has not been shown to be safe or effective as a COVID-19 treatment.

This approval was granted to Arbor Pharmaceuticals LLC.