Ulesfia

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Treatment & Uses
Side Effects

Generic Name: benzyl alcohol lotion 5%
Date of Approval: April 9, 2009
Company: Sciele Pharma, Inc.

Treatment for: Head Lice

FDA Approves Ulesfia

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The U.S. Food & Drug Administration (FDA) has approved Ulesfia, the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects.

Each year, approximately 6 to 12 million children between the ages of 3 and 12 years are infested with head lice. To survive, lice breathe through sophisticated spiracles that close upon contact with most liquids, allowing the lice to go into suspended animation and survive for hours without respiration. Benzyl alcohol prevents lice from closing their spiracles, thereby asphyxiating them within ten minutes and causing death.

Ulesfia Patient Information

Read the Patient Information that comes with Ulesfia before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Note: For use on scalp hair and scalp only

What is Ulesfia?

Ulesfia is a prescription medicine used to get rid of lice in scalp hair of children and adults. It is not known if Ulesfia is safe for children under 6 months of age or in people over age 60.

Once Ulesfia is washed off, a fine-tooth comb may be used to remove treated lice and nits from the hair and scalp. All personal items exposed to the hair or lice should be washed in hot water or dry-cleaned. See "How do I stop the spread of lice?" at the end of this leaflet.

What should I tell my healthcare provider before I use Ulesfia?

Tell your healthcare provider if your baby was born early so your healthcare provider can decide if your infant is old enough for Ulesfia.

Tell your healthcare provider about all of your medical conditions, including if you:

have any skin conditions or sensitivities,
are pregnant or planning to become pregnant. It is not known if Ulesfia can harm your unborn baby,
are breastfeeding. It is not known if Ulesfia passes into your breast milk or if it can harm your baby. You should choose to breastfeed or use Ulesfia, but not both. Talk to your healthcare provider about other ways to feed your baby while using Ulesfia.

How should I use Ulesfia?

Use Ulesfia exactly as prescribed. Your healthcare provider will prescribe the treatment that is right for you. Do not change your treatment unless you talk to your healthcare provider.
Use Ulesfia in two treatments that are one week apart. Ulesfia gets rid of lice but does not get rid of lice eggs so a second treatment is needed one week (7 days) after the first treatment.
Ulesfia coats the lice on your scalp and scalp hair. It is important to use enough Ulesfia to coat completely every single louse and to leave it on your scalp for the full 10 minutes. See the detailed Patient Instructions for Use at the end of this leaflet.
Because you need to completely cover all of the lice with Ulesfia, you may need help in applying Ulesfia to your scalp and hair. Make sure that you and anyone who helps you apply Ulesfia reads and understands this leaflet and the Patient Instructions for Use.
Children need adult help in applying Ulesfia.
Do not get into eyes. If Ulesfia gets in the eye, flush with water right away.
Do not swallow Ulesfia. If swallowed, call your healthcare provider right away.
Wash your hands after you apply Ulesfia.

What are the possible side effects of Ulesfia?

People using Ulesfia may have skin or eye:

itching,
redness,
irritation. If skin or eye irritation happens, rinse with water right away, then call your healthcare provider or go to the emergency department.

These are not all the side effects of Ulesfia. For more information, ask your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store Ulesfia?

Store Ulesfia in a dry place at room temperature, (59 °to 86° F or 15°to 30° C).
Do not freeze Ulesfia.

Keep Ulesfia and all medicines out of the reach of children.

What are the ingredients in Ulesfia?

Active ingredient: benzyl alcohol, 5%
Inactive ingredients: purified water, mineral oil, sorbitan monooleate, polysorbate 80, carbomer 934P and trolamine

General Information about Ulesfia

Medicines are sometimes prescribed for conditions other than those described in the patient information leaflets. Do not use Ulesfia for any condition for which it was not prescribed by your healthcare provider. Do not give Ulesfia to other people, even if they have the same symptoms as you. It may harm them.

This leaflet summarizes the most important information about Ulesfia. If you would like more information, talk to your healthcare provider. You can also ask your healthcare provider for information about Ulesfia that is written for healthcare professionals.

For more information, please see Benzyl Alcohol Lotion 5% Product Label (PDF)