Ulesfia™ (benzyl alcohol) Lotion

Information from Ulesfia website at www.ulesfialotion.com

The first non-neurotoxic, FDA approved prescription product for treating head lice.

Ulesfia is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia Lotion does not have ovicidal activity.

Dosage and Administration

1. Apply sufficient Ulesfia Lotion to dry hair to completely saturate the scalp and hair
2. Leave on for 10 minutes
3. Thoroughly rinse off with water
4. Repeat treatment after 7 days. Avoid contact with eyes

Safety Information

Intravenous administration of products containing benzyl alcohol has been associated with neonatal gasping syndrome. Neonates (i.e. patients less than 1 month of age or preterm infants with a corrected age of less than 44 weeks) could be at risk of gasping syndrome if treated with Ulesfia Lotion

Avoid Eye Exposure. Protect eyes during product application.  Flush immediately with water if Ulesfia Lotion comes into contact with eyes. Consult a physician if eye irritation persists.

Contact dermatitis may occur with Ulesfia Lotion. If skin irritation occurs, immediately rinse with water and discontinue use of the product until irritation clears. If irritation continues, consult a physician.

Keep out of reach of children. Ulesfia Lotion should only be used on children under the direct supervision of an adult. For external use only; use only on scalp and scalp hair.

Most common application site adverse reactions were: application site irritation (2%), and application site anesthesia and hypoesthesia (2%) and pain (1%)

In a subset of subjects without symptoms prior to treatment, the most common monitored adverse reactions after treatment were: pruritus (12%), erthema (10%), pyoderma (7%), and ocular irritation (6%).

Ulesfia^TM Lotion is a trademark of Sciele Pharma, Inc.