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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ULESFIA® Lotion safely and effectively. See full prescribing information
for ULESFIA Lotion.
Ulesfia (benzyl alcohol) Lotion
For topical use only
Initial U.S. Approval: 2009
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.
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.
--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 interaction studies were not conducted.
USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety in pediatric patients under six months of
age has not been established.
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.
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
Store at 20º - 25º C (68º - 77º F); excursions permitted to 15º
- 30º C (59º - 86º F) [See USP controlled room temperature]..