Permethrin is an anti-parasite medication.

Nix Complete Lice Treatment System (for the skin) is used to treat head lice and scabies.

Nix Complete Lice Treatment System may also be used for other 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.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

You may have a temporary increase in itching, swelling, or redness of treated skin when you first start using Nix Complete Lice Treatment System.

Do not take by mouth. This medicine is for use only on the skin. Do not apply to open cuts or wounds. If the medicine gets in your eyes or mouth, rinse with water. Use the surface spray only on household surfaces and not on your skin.

You may need to shake the medicine before each use. Follow the directions on the medicine label.

To treat scabies:

• Clean and dry the skin. Apply a thin layer of this medicine to all body parts from the neck down to the soles of the feet. Rub in completely. Leave the medicine on your skin for 8 to 14 hours, then wash it off completely.

• When using Nix Complete Lice Treatment System on an infant, also apply the medicine to the scalp, temples, and forehead. Avoid applying near the eyes, nose, mouth, or genitals.

• If your condition does not clear up within 14 days, apply Nix Complete Lice Treatment System again.

To treat head lice:

• Wash your hair using shampoo only (no conditioner or 2-in-1 shampoo). Rinse thoroughly and towel dry the hair, leaving it damp.

• Protect your eyes with a towel or washcloth. Apply the medicine to completely saturate all hair, and leave it in for 10 minutes. Then rinse with warm water.

• You may also use a nit comb to remove lice eggs from the hair. Your hair should be slightly damp while using a nit comb. Work on only one section of hair at a time, combing through 1 to 2-inch strands from the scalp to the ends.

• Rinse the nit comb often during use. Place removed nits into a sealed plastic bag and throw it into the trash.

• Check the scalp again daily to make sure all nits have been removed.

• If you still see lice 7 days after your first treatment, use a second application.

To treat pubic lice (crabs):

• All sexual partners should be treated.

• Wash and dry the treatment area. Apply Nix Complete Lice Treatment System to all pubic hair and any surrounding hairs on the thighs and around the anus (avoid areas inside the rectum or vagina).

• Leave the medicine on for 10 minutes. Then work into a lather and rinse thoroughly with warm water.

• You may also use a nit comb to remove lice eggs from pubic hair (hair should be slightly damp).

To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, and towels in hot water and dry in high heat. Dry-clean any non-washable clothing. Soak all hair brushes, combs, and hair accessories in hot water for at least 10 minutes.

Use permethrin surface spray to disinfect non-washable items such as:

• furniture;

• mattresses and pillows;

• stuffed toys;

• hats, gloves, and scarves;

• headphones or headbands;

• the inside of a bike helmet; or

• seats and carpets inside your car.

Stuffed toys or pillows that cannot be washed should be sealed in air-tight plastic bags for 4 weeks. After removing from the bag, vigorously shake the item outdoors.

Vacuum all rugs, carpets, and car seats. Then throw away the vacuum cleaner bag.

For the most complete treatment of lice or scabies, you must treat your environment (clothing, bedding, etc) at the same time you treat your hair and/or body.

Store Nix Complete Lice Treatment System at room temperature away from moisture and heat.

You should not use Nix Complete Lice Treatment System if you are allergic to permethrin or to chrysanthemums.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions.

Nix Complete Lice Treatment System is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant.

It is not known whether permethrin topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Nix Complete Lice Treatment System should not be used on a child younger than 2 months old.

Since Nix Complete Lice Treatment System is usually needed only once, you are not likely to be on a dosing schedule. Wait at least 7 days before using a second application.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if you think you have used too much, or if anyone has accidentally swallowed the medication.

Rinse with water if Nix Complete Lice Treatment System gets in your eyes.

Lice and scabies infections are highly contagious. Avoid sexual or intimate contact with others until your lice or scabies infection has cleared up. Avoid sharing hair brushes, combs, hair accessories, hats, clothing, bed linens, and other articles of personal use.

Avoid using other medications on the areas you treat with Nix Complete Lice Treatment System, unless your doctor tells you to.

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

Call your doctor at once if you have severe burning, stinging, redness, or swelling after applying Nix Complete Lice Treatment System.

Common side effects of Nix Complete Lice Treatment System may include:

• mild burning, stinging, itching or mild rash;

• numbness or tingling where the medicine was applied;

• headache, dizziness;

• fever; or

• stomach pain, nausea, vomiting, diarrhea.

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.