Soolantra is a prescription cream used to treat rosacea.

Soolantra contains ivermectin, a macrocyclic lactone. Exactly how it works to treat rosacea is unknown.

• Do not get this medicine in your eyes, nose, or mouth. Do not get it in your vagina. If you get this medicine in any of these areas, gently flush them with water.
• Do not use more than the recommended dose or for longer than prescribed without checking with your doctor.
• This medicine may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• PREGNANCY and BREASTFEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. It is not known if this medicine is found in breast milk after topical use. Do not breastfeed while using this medicine.

Use this medicine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet and instructions for use is available with this medicine. Talk to your pharmacist if you have questions about this information.
• Be sure you understand how to use this medicine. Ask your health care provider if you have questions or if you are unsure how to use it.
• Wash your hands before and after using this medicine.
• Clean the affected area before use. Make sure to dry well.
• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed.
• Avoid getting this medicine in the eyes or on the lips.
• If you miss a dose of this medicine, put it on as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not put on 2 doses at once.

Instructions for Use

Important: Soolantra cream is for use on the face only. Do not use Soolantra cream in your eyes, mouth or vagina.
Read and follow the steps below so that you use Soolantra cream correctly:

1. Open the tube of Soolantra cream by gently pressing down on the child resistant cap and twist in the direction of the arrow (counterclockwise). To avoid spilling, do not squeeze the tube while opening or closing.
2. To apply Soolantra cream to your face, squeeze a pea-sized amount of Soolantra cream from the tube onto your fingertip.
3. Apply Soolantra to the affected areas of your face once a day. Use a pea-sized amount of Soolantra cream for each area of your face (forehead, chin, nose, each cheek) that is affected. Spread the cream smoothly and evenly in a thin layer. Avoid contact with your eyes and lips.
4. To close Soolantra cream, gently press down on the child resistant cap and twist to the right (clockwise).

Ask your health care provider any questions you may have about how to use this medicine.

You should not use Soolantra if you are allergic to ivermectin or any of the other ingredients contained in this medicine.

Before using Soolantra

Some medical conditions may interact with this medicine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with this medicine. Because little, if any, of this medicine is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if this medicine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these common side effects persists or becomes bothersome:

• Mild burning at the application site; skin irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

• Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent burning at the application site; severe or persistent skin irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.