May 28, 2016
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Ulesfia

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Ulesfia




PATIENT INFORMATION

ULESFIA®
(Yoo-Les-fee-ah)
(benzyl alcohol 5%) Lotion

Read the Patient Information that comes with ULESFIA® Lotion 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® Lotion?

ULESFIA® Lotion is a prescription medicine used to get rid of lice in scalp hair of children and adults.

It is not known if ULESFIA® Lotion is safe for children under 6 months of age or in people over age 60.

Once ULESFIA® Lotion 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® Lotion?

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

Before you use ULESFIA® Lotion, tell your healthcare provider if you:

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

How should I use ULESFIA® Lotion?

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

What are the possible side effects of ULESFIA® Lotion?

People using ULESFIA® Lotion 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.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of ULESFIA® Lotion. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ULESFIA® Lotion?

  • Store ULESFIA® Lotion in a dry place at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not freeze ULESFIA® Lotion.

Keep ULESFIA® Lotion and all medicines out of the reach of children.

What are the ingredients in ULESFIA® Lotion?

Active ingredient: benzyl alcohol, 5%

Inactive ingredients: purified water, mineral oil, sorbitan monooleate, polysorbate 80, carbomer 934P and trolamine

General Information about ULESFIA® Lotion

Medicines are sometimes prescribed for conditions other than those described in the Patient Information leaflet. Do not use ULESFIA® Lotion for any condition for which it was not prescribed by your healthcare provider. Do not give ULESFIA® Lotion 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® Lotion. If you would like more information, talk to your healthcare provider. You can also ask your healthcare provider for information about ULESFIA® Lotion that is written for healthcare professionals.

Instructions for Use

Apply the full amount of ULESFIA® Lotion prescribed by your healthcare provider for each of your 2 applications one week apart. ULESFIA® Lotion gets rid of lice but does not get rid of lice eggs so a second application is needed one week (7 days) after the first application.

ULESFIA® Lotion comes in a single 8 oz. bottle, and in a 2 pack containing two 8 oz. bottles with a lice comb. For different hair lengths, use the following as a guide for the amount of ULESFIA® Lotion you may need to cover the hair and scalp completely:

Hair Length Amount of ULESFIA® Lotion to apply each time
8 oz. bottle
Short- up to 2 inches up to 3/4 the bottle
Short- 2-4 inches up to 1 bottle
Medium- 4-8 inches up to 1½ bottles
Medium- 8-16 inches up to 3 bottles
Long- 16-22 inches up to 4 bottles
Long- 22 inches or more up to 6 bottles

Step 1

Cover your face and eyes with a towel - Illustration

  • Cover your face and eyes with a towel and keep your eyes closed tightly.
  • Apply ULESFIA® Lotion directly to dry scalp and dry hair.
  • ULESFIA® Lotion must cover your entire scalp and all scalp hair. Have an adult help you apply ULESFIA® Lotion.

Step 2

Massage ULESFIA® Lotion into your hair and scalp -  Illustration

  • Massage ULESFIA® Lotion into your hair and scalp.
  • When your head is completely covered with enough ULESFIA® Lotion, dripping will happen. Protect your eyes and skin from these drips with your towel.

Massage ULESFIA® Lotion into your hair and scalp -  Illustration

  • Be sure to apply ULESFIA® Lotion to the area behind your ears.

Apply ULESFIA® Lotion to the area behind your ears - Illustration

  • Be sure to apply ULESFIA® Lotion to the back of your neck.
  • If not enough ULESFIA® Lotion is used, some lice may escape treatment. It is important to use the full amount of ULESFIA® Lotion prescribed by your healthcare provider.

Apply ULESFIA® Lotion to the back of your neck - Illustration

Correct application of ULESFIA® Lotion.

Step 3

Allow ULESFIA® Lotion to stay on your hair for 10 minutes - Illustration

  • Allow ULESFIA® Lotion to stay on your hair for 10 minutes. Use a timer or clock.
  • Start timing after you have completely covered your hair and scalp with ULESFIA® Lotion.

Step 4

Rinse ULESFIA® Lotion from your hair and scalp with water - Illustration

  • After 10 minutes, completely rinse ULESFIA® Lotion from your hair and scalp with water.
  • You or anyone who helps you apply ULESFIA® Lotion should wash your hands after application.
  • You can shampoo your hair right after the application.
  • A lice comb may be used to remove the dead lice after both applications.

Step 5

One week (7 days) after your first application, repeat the steps above to help get rid of lice that hatched from eggs.

How do I stop the spread of lice?

To help prevent the spread of lice from one person to another, here are some steps you can take.

  • Avoid head-to-head contact at school, on the playground, in physical education classes, during sports activities, and while playing with other children.
  • Do not share combs, brushes, hats, scarves, bandannas, ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal items with anyone else, whether they have lice or not.
  • Avoid sleepovers and slumber parties during lice outbreaks. Lice can live in bedding, pillows, and carpets that have recently been used by someone with lice.
  • After finishing treatment with lice medicine, check everyone in your family for lice after one week. Be sure to talk to your healthcare provider about treatments for those who have lice.
  • Machine-wash any bedding and clothing used by anyone having lice or thought to have been exposed to lice. Machine wash at high temperatures (150°F) and tumble in a hot dryer for 20 minutes.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/17/2016
This monograph has been modified to include the generic and brand name in many instances.

Ulesfia - User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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