Uses of Spinosad:

• It is used to treat head lice.

What do I need to tell my doctor BEFORE I take Spinosad?

For all patients taking spinosad:

• If you have an allergy to spinosad or any other part of spinosad.
• If you are allergic to spinosad; any part of spinosad; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

Children:

• If your child is younger than 6 months of age. Do not give spinosad to an infant younger than 6 months of age.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take spinosad with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Spinosad?

• Tell all of your health care providers that you take spinosad. This includes your doctors, nurses, pharmacists, and dentists.
• Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
• This medicine may cause harm if swallowed. If spinosad is swallowed, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using spinosad while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Spinosad) best taken?

Use spinosad as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to use carefully.
• Do not take spinosad by mouth. Use on your scalp and hair only. Keep out of your mouth, nose, ears, and eyes (may burn).
• Wash your hands before and after use.
• Cover eyes and face with a towel. Keep eyes closed tightly.
• Shake well before use.
• Do not wet hair before putting spinosad on.
• Coat hair and scalp.
• Leave on for 10 minutes.
• Rinse fully with warm water. You may use shampoo after spinosad is rinsed out.
• You may use a special nit comb or tweezers to get rid of dead nits (lice eggs) from hair, but you do not have to get rid of the nits. The lotion kills the nits too.
• Wash all hair combs, brushes, hair clips, bedding, towels, and recently worn clothes in hot water or have them dry cleaned.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Skin irritation.
• Eye irritation.

What are some other side effects of Spinosad?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Spinosad?

• Store at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about spinosad, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.