Last reviewed 2026-04-20 · How we verify

Ulesfia (BENZYL ALCOHOL)

Ulesfia (BENZYL ALCOHOL) is a small molecule pediculicide developed by Shionogi Inc, currently owned by the same company. It was FDA approved in 2009 for the treatment of itching of the skin and skin irritation. Ulesfia is off-patent, with no active Orange Book patents. As a pediculicide, it targets and kills lice and their eggs. It is commercially available, but there are no generic manufacturers.

At a glance

Approved indications

• Itching of skin
• Skin irritation

Common side effects

• Peripheral swelling
• Arthralgia
• Hypothyroidism
• Elevated HbA1c
• Eosinophilia
• Hematoma
• Headache
• Hypertriglyceridemia
• Leg pain
• Injection site reactions/rashes
• Lipoatrophy
• Peripheral edema

Serious adverse events

• Benign intracranial hypertension
• Central precocious puberty
• Aggravation of preexisting scoliosis

Key clinical trials

• Effectiveness of Vitamin b12 Versus Kenalog on Traumatic Ulcer Associated With Orthodontic Treatment (NA)
• A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer (PHASE3)
• Sublingual Atropine Bioequivalence by Route of Administration (SABER) (PHASE1)
• Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC) (PHASE2)
• Study of Healthy Aging and Physical Function With Elamipretide (PHASE2)
• Safety, Tolerability, and Systemic Exposure of Apo-Si- K170A-C76 in Healthy Volunteers (PHASE1)
• Effect of Topical Agents With Various Antioxidant Containts on Photodamage Skin Induced (PHASE2)
• Hydrocortisone for BPD (PHASE3)

Primary sources

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