Description

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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.

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.

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.