Natroba

1-10%

Application site erythema (3%)

Ocular erythema (2%)

Ocular hyperemia (2%)

Application site irritation (1%)

<1%

Application site dryness

Application site exfoliation

Alopecia

Dry skin

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.

Pediculicide.1 2 14

No formal drug interaction studies to date.1

Spinosad 0.9% topical suspension is used to treat head lice infestations.

This medicine is available only with your doctor's prescription.

Benzyl Alcohol Toxicity

Natroba Topical Suspension contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants [See Use in Specific Populations (8.4)].

Natroba (spinosad) is an anti-parasite medicine.

Natroba topical suspension is used to treat head lice in adults and children who are at least 6 months old.

Natroba may also be used for purposes not listed in this medication guide.

Do not use this medication on a child or infant without medical advice. Natroba 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 Natroba without supervision of an adult.

It is not known whether spinosad passes into breast milk. However, this medication contains a preservative that may be harmful to a newborn. Do not breast-feed within 8 hours after applying Natroba topical suspension. Do not take this medication by mouth. It is for use only on the hair and scalp. Do not apply Natroba to sunburned, irritated, or broken skin.

Use Natroba topical suspension on scalp hair only. Apply this medication to dry hair only. Do not wet your hair or scalp before using this medicine.

Avoid getting Natroba in your eyes, mouth, or vagina. If this does happen, rinse with water. 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. 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. Hair brushes, combs, and hair accessories should be soaked in hot water for at least 10 minutes.

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.

You should not use Natroba if you are allergic to spinosad.

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

This medicine 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, Natroba topical suspension contains a preservative that may be harmful to a newborn. Do not breast-feed within 8 hours after applying Natroba topical suspension. 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. Natroba topical suspension 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 Natroba without supervision of an adult.

Get emergency medical help if you have signs of an allergic reaction to Natroba: 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 Natroba.

Common Natroba side effects 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.

It is not likely that other drugs you take orally or inject will have an effect on topically applied spinosad. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

LactMed Record Number

843

Last Revision Date

20150310

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Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.