| 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
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.
| CLINICAL PHARMACOLOGY
Mechanism of Action
| INDICATIONS AND USAGE
--Ulesfia Lotion is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older.
--Ulesfia Lotion does not have ovocidal activity.
| WARNINGS AND PRECAUTIONS
--Neonatal toxicity: Risk of gasping syndrome if benzyl alcohol is used in neonates.
USE IN SPECIFIC POPULATIONS
| Most common adverse reactions (> 1% and more common than with placebo): ocular irritation, application site irritation, and application site anesthesia and hypoesthesia.
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.
| DOSAGE AND ADMINISTRATION
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
| HOW SUPPLIED/STORAGE AND HANDLING
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.
| Package Insert data:
8 oz. (227 g)
For topical use on the scalp
SHIONOGI PHARMA, INC.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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