Nix Lice Control

You should not use this medicine 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.

Permethrin topical 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.

Permethrin topical should not be used on a child younger than 2 months old.

Rinse with water if this medicine 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 permethrin topical, 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 permethrin topical.

Common side effects 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.

Applies to permethrin topical: topical cream, topical liquid, topical lotion, topical spray

Along with its needed effects, permethrin topical (the active ingredient contained in Nix Lice Control) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of permethrin topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, itching, numbness, rash, redness, stinging, swelling, or tingling of the scalp

Applies to permethrin topical: topical cream, topical kit, topical lotion, topical solution, topical spray

Local

Local side effects have included mild and transient burning and stinging usually associated with the severity of infestation.[Ref]

Dermatologic

Dermatological side effects have included pruritus (7%), erythema (1% to 2%), and rash (1% to 2%).[Ref]

Nervous system

Nervous system side effects have included numbness and tingling (1% to 2%). Headache and dizziness have also been reported. Rare occurrences of seizure have been reported; however, an association with the use of permethrin topical (the active ingredient contained in Nix Lice Control) has not been confirmed.[Ref]

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, diarrhea, and nausea and/or vomiting.[Ref]

General

General side effects have included fever.[Ref]

Some side effects of Nix Lice Control may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.