Spinosad is an anti-parasite medicine.

Spinosad topical (for the skin) is used to treat head lice in adults and children who are at least 6 months old.

Spinosad 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. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

Shake the bottle well just before you use the medicine.

Use spinosad topical on scalp hair only. Apply this medicine to dry hair only. Use a towel to cover your face and eyes. Keep your eyes tightly closed during application.

Do not wet your hair or scalp before using spinosad topical. Do not apply spinosad topical to sunburned, irritated, or broken skin.

Apply enough spinosad topical to completely cover your scalp and hair. Apply the medicine to the scalp first and then onto the hair from roots to ends.

Remove the medicine from your hands with soap and water after you apply spinosad topical.

Leave the medicine in your hair for 10 minutes, keeping your eyes closed and covered during this time. Then rinse the medicine out thoroughly with warm water.

You may also use a nit comb to remove lice eggs from the damp hair. 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 to prevent re-infestation.

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

Use a second application of spinosad topical if lice are still seen 7 days after your first treatment.

For the most complete treatment of head lice and to prevent reinfection, you must treat your environment at the same time you treat your scalp.

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 for at least 10 minutes. Vacuum all rugs and carpets and throw away the vacuum cleaner bag.

Store spinosad topical at room temperature away from moisture and heat.

Usual Adult Dose for Lice:

Apply enough topical suspension to cover dry scalp, then apply to dry hair; leave on for 10 minutes, then thoroughly rinse off the drug with warm water.

Comments:
-Depending on hair length, up to 120 mL may be used to sufficiently cover scalp and hair.
-A second treatment should be applied if live lice are seen 7 days after the first treatment.

Use: For the topical treatment of head lice infestation

Usual Pediatric Dose for Lice:

6 months or older: Apply enough topical suspension to cover dry scalp, then apply to dry hair; leave on for 10 minutes, then thoroughly rinse off the drug with warm water.

Comments:
-Depending on hair length, up to 120 mL may be used to sufficiently cover scalp and hair.
-A second treatment should be applied if live lice are seen 7 days after the first treatment.

Use: For the topical treatment of head lice infestation

You should not use spinosad topical if you are allergic to it.

To make sure you can safely use spinosad topical, tell your doctor if you have any conditions that make your skin sensitive.

spinosad topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether spinosad topical passes into breast milk. However, this medicine contains a preservative that may be harmful to a newborn. Do not breast-feed within 8 hours after applying spinosad topical. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Do not use this medicine on an infant without medical advice. Spinosad topical contains an ingredient that can cause serious side effects or death in very young infants or premature babies. Do not allow an older child to use spinosad without supervision of an adult.

Since spinosad topical is usually needed only once, it does not have a daily 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 anyone has accidentally swallowed the medication.

Avoid getting this medication in your eyes, mouth, or vagina. If this does happen, rinse with water.

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

Do not use other medicated scalp products 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.

Rinse off the medicine and call your doctor at once if you have severe burning, stinging, or irritation after applying spinosad topical.

Common side effects of spinosad topical may include:

• scalp redness or irritation; or

• eye redness or irritation.

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.