Ulesfia lotion is an anti-parasite medication.

Ulesfia lotion is used to treat head lice in people between 6 months of age and 60 years old.

Ulesfia is for treating head lice only. It will not treat lice on other body areas.

Ulesfia lotion is used to treat head lice in people between the ages of 6 months and 60 years old. This medicine will not treat lice on other body areas.

Do not use Ulesfia on a child or infant younger than 6 months old.

If Ulesfia lotion gets in your eyes or on your skin, rinse with water. Call your doctor at once if you have severe stinging, itching, or irritation of the eyes or skin after rinsing.

Avoid head to head contact with others. Avoid sharing hair brushes, combs, hair accessories, hats, scarves, and pillows. Lice infections are highly contagious.

Before taking this medicine

To make sure Ulesfia is safe for you, tell your doctor if you have ever had:

• any skin conditions; or

• any other medical conditions.

Ulesfia lotion contains an ingredient that can cause serious side effects or death in very young or premature babies.

• Do not use Ulesfia lotion on an infant younger than 6 months old, and tell your healthcare provider if your baby was born prematurely.

Tell your doctor if you are pregnant or breastfeeding.

You should not breastfeed while using Ulesfia.

How should I use Ulesfia?

Use Ulesfia lotion exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not allow a young child to use this medicine without help from an adult.

Do not take Ulesfia by mouth. It is for use only on the hair and scalp.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands with soap and water after applying this medicine.

Do not wet your hair or scalp before applying Ulesfia lotion. Apply enough lotion to completely soak your scalp and hair and massage in thoroughly.

Leave the lotion on for 10 minutes, keeping your eyes closed and covered with a towel during this time. Then rinse out thoroughly with water. Use a fine-tooth nit comb to remove lice eggs from the hair, rinsing the comb often during use. Place removed nits into a sealed plastic bag and throw it into the trash to prevent re-infestation.

Ulesfia will not get rid of lice eggs so you must use a second application of this medicine 7 days after the first use.

Wash all clothing, hats, bed clothes, bed linens, and towels in hot water and dry in high heat. Dry-clean any non-washable clothing. Hair brushes, combs, and hair accessories should be soaked in hot water.

Store at room temperature away from moisture and heat. Do not freeze.

Use Ulesfia lotion exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not allow a young child to use this medicine without help from an adult.

Do not take Ulesfia by mouth. It is for use only on the hair and scalp.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands with soap and water after applying this medicine.

Do not wet your hair or scalp before applying Ulesfia lotion. Apply enough lotion to completely soak your scalp and hair and massage in thoroughly.

Leave the lotion on for 10 minutes, keeping your eyes closed and covered with a towel during this time. Then rinse out thoroughly with water. Use a fine-tooth nit comb to remove lice eggs from the hair, rinsing the comb often during use. Place removed nits into a sealed plastic bag and throw it into the trash to prevent re-infestation.

Ulesfia will not get rid of lice eggs so you must use a second application of this medicine 7 days after the first use.

Wash all clothing, hats, bed clothes, bed linens, and towels in hot water and dry in high heat. Dry-clean any non-washable clothing. Hair brushes, combs, and hair accessories should be soaked in hot water.

Store at room temperature away from moisture and heat. Do not freeze.

To make sure Ulesfia is safe for you, tell your doctor if you have ever had:

• any skin conditions; or

• any other medical conditions.

Ulesfia lotion contains an ingredient that can cause serious side effects or death in very young or premature babies.

• Do not use Ulesfia lotion on an infant younger than 6 months old, and tell your healthcare provider if your baby was born prematurely.

Tell your doctor if you are pregnant or breastfeeding.

You should not breastfeed while using Ulesfia.

Ask your doctor if you missed your second application of Ulesfia lotion.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed this medication.

Avoid getting this medicine in your eyes.

Avoid getting Ulesfia lotion in your eyes or mouth. It is for use only on the hair and scalp.

To prevent spreading lice, avoid head to head contact with others until your lice infection has cleared up. Avoid sharing hair brushes, combs, hair accessories, hats, scarves, and pillows. Lice infections are highly contagious.

Get emergency medical help if you have signs of an allergic reaction to Ulesfia: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If the medicine gets in your eyes or on your skin, rinse with water. Call your doctor at once if you have severe stinging, itching, or irritation of the eyes or skin after rinsing.

Stop using this medicine and call your doctor at once if you have:

• swelling;

• skin rash;

• fever; or

• worsening pain, redness, or irritation.

Common Ulesfia side effects may include:

• eye irritation; or

• numbness or irritation after applying this medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.