The Ulesfia brand of benzyl alcohol topical is used to treat head lice in people between 6 months of age and 60 years old.

The Zilactin brand of benzyl alcohol topical is used to treat sores in or around the mouth, including cold sores, canker sores, or irritated gums. Zilactin is for use in adults and chlidren at least 2 years old.

Benzyl alcohol topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not allow a young child to use benzyl alcohol topical without help from an adult.

Do not take Ulesfia by mouth. It is for use only on the hair and scalp. You may apply Zilactin to sores inside the mouth, but do not swallow the gel.

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. 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.

Benzyl alcohol topical 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.

Apply Zilactin only to a cold sore or mouth sore, not to the surrounding skin or gum area.

Zilactin gel dries into a clear protective film. To remove this film, first apply another coat of the gel and then wipe the area with a moist gauze pad or tissue. Do not try and peel off the film.

Do not use Zilactin for longer than 7 days in a row. Stop using the medicine and call your doctor if your mouth sore does not improve after 7 days, if it gets worse, or if it clears up and then comes back in a few days.

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

Zilactin is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Tell your doctor if you have ever had:

• any skin conditions; or

• any other medical conditions.

Benzyl alcohol topical contains an ingredient that can cause serious side effects or death in very young or premature babies.

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

• Do not use Zilactin on a child younger than 2 years old.

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.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Avoid getting benzyl alcohol topical in your eyes.

Avoid getting Ulesfia 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: 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.

This medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• swelling;

• skin rash;

• fever; or

• worsening pain, redness, or irritation.

Common side effects of benzyl alcohol topical 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.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Your prescription is probably not refillable. If you feel you need additional treatment, call your doctor.

Lice are generally spread by close head-to-head contact or from items which come in contact with your head. Do not share combs, brushes, towels, pillows, hats, scarves, or hair accessories. Be sure to check everyone in your immediate family for head lice if another family member is being treated for lice.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.