Natroba (spinosad)

Natroba may cause serious side effects including:

• hives,
• rash,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat, and
• severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Natroba include:

• skin or eye irritation or rednes

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Natroba. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Important Administration Instructions

• For topical use only. Natroba is not for oral, ophthalmic, or intravaginal use.
• Avoid contact with eyes. If Natroba gets in or near the eyes, rinse thoroughly with water.

Treatment Of Head Lice Infestations

• Shake bottle well.
• Apply a sufficient amount of Natroba to cover dry scalp, then apply to dry hair. Depending on hair length, apply up to 120 mL (one bottle) to adequately cover scalp and hair.
• Leave on for 10 minutes, then thoroughly rinse off with warm water.
• Wash hands after use.
• If live lice are seen 7 days after the first treatment, a second treatment should be applied.
• Apply Natroba on pediatric patient only under direct supervision of an adult.

Treatment Of Scabies Infestations

• Shake bottle well.
• Apply a sufficient amount of Natroba to skin to completely cover the body from the neck to the toes (including the soles of the feet).
• For patients with balding scalp, also apply product to the scalp, hairline, temples, and forehead.
• Allow to absorb into the skin and dry for 10 minutes before getting dressed.
• Leave on the skin for at least 6 hours before showering or bathing.
• Apply Natroba on pediatric patient only under direct supervision of an adult.

• Spinosad, the active ingredient in Natroba, is not absorbed systemically following topical application, and maternal use is not expected to result in fetal exposure to the drug.
• Natroba contains benzyl alcohol. Topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to the drug.
• Spinosad, the active ingredient in Natroba, is not systemically absorbed by the mother following topical application. Therefore, breastfeeding is not expected to result in the exposure of the child to spinosad.
• Breastfeeding women should remove Natroba from the breast by washing with soap and water before breastfeeding to avoid direct infant exposure to Natroba.