Ulesfia® (benzyl alcohol) Lotion

Ulesfia (benzyl alcohol) Lotion
For topical use only
Initial U.S. Approval: 2009

DESCRIPTION
Ulesfia (benzyl alcohol) Lotion is supplied as a white topical lotion containing benzyl alcohol, 5%. Inactive ingredients in this formulation are water, mineral oil, sorbitan monooleate, polysorbate 80, carbomer 934P and trolamine.

The active ingredient, benzyl alcohol, is a clear, colorless liquid with a mild aromatic odor. Benzyl alcohol has a molecular mass of 108.14 g/mol. The molecular formula is C7H8O.

Mechanism of Action
In vitro studies of the effect of Ulesfia Lotion on native, captured lice suggest that benzyl alcohol inhibits lice from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles and causing the lice to asphyxiate.

Pharmacokinetics
The absorption of benzyl alcohol from Ulesfia Lotion was evaluated in 19 subjects with head lice infestation. Subjects were divided into two age groups: 6 months to 3 years and 4 to 11 years. Ulesfia Lotion was applied for an exaggerated exposure period (3 times the normal exposure period). Benzyl alcohol was quantified in a single plasma sample in 4 out of 19 subjects (21%): three subjects in the 6 months to 3 years age group at 0.5 hour post-treatment (ranging from 1.97 to 2.99 mcg/mL) and one subject in the 4 to 11 year age group (1.63 mcg/mL) at 1 hour post-treatment out of a total of 102 samples analyzed.

--Ulesfia Lotion does not have ovocidal activity.

--Neonatal toxicity: Risk of gasping syndrome if benzyl alcohol is used in neonates.
--Eye irritation: Avoid eye exposure. Flush immediately with water if Ulesfia Lotion comes into contact with eyes.
--Contact dermatitis: May occur with Ulesfia Lotion.
--Use in children: Ulesfia Lotion should only be used on children under the direct supervision of an adult. Keep out of reach of children.

DRUG INTERACTIONS
Drug interaction studies were not conducted.

USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety in pediatric patients under six months of age has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Pharma, Inc. Drug Safety at 1-800-849-9707 ext. 1454 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Ulesfia Lotion is not for oral, ophthalmic, or intravaginal use.

Using the guideline in Table1, apply sufficient Ulesfia Lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat treatment after 7 days. Avoid contact with eyes.

Table 1: Ulesfia Lotion Usage Guideline

Ulesfia Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion) supplied as 4 fl oz (113 g) (NDC 59630-780-04) or as 8 fl oz (227 g) (NDC 59630-780-08) in polypropylene bottles.

Store at 20º - 25º C (68º - 77º F); excursions permitted to 15º - 30º C (59º - 86º F) [See USP controlled room temperature]..

Do not freeze. Keep out of reach of children.

8 oz. (227 g)
Rx ONLY

For topical use on the scalp
hair and scalp only.

SHIONOGI PHARMA, INC.

DISTRIBUTED BY:
Shionogi Pharma, Inc.
Atlanta, GA 30328

MANUFACTURED BY:
Contract Pharmaceuticals Limited
Mississauga, ON L5N 6L6
Made in Canada