Rosula

You should not use this medicine if you are allergic to sulfa drugs or if you have kidney disease.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not use on sunburned, windburned, dry, chapped, irritated, or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and sulfur topical 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.

Stop using this medicine and call your doctor at once if you have:

• new or worsening skin rash;

• joint pain;

• fever; or

• mouth sores.

Common side effects may include:

• redness, warmth, swelling, itching, stinging, burning, or irritation of treated skin.

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.

Although rare, severe hypersensitivity reactions to sulfonamides include Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. At the first sign of hypersensitivity or skin rash, discontinue use of this preparation. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120°F (49°C).

Although infrequent, sodium sulfacetamide may cause local irritation.

Wash affected areas before use, 1 to 2 times daily as directed by physician. Before each use, shake can vigorously, then gently tap the bottom of the can on a firm surface or in palm of other hand. Tap can 1-2 times, thenshake and tap again.

Invert can so nozzle points down. (Dispensing with the can held upright will cause a loss of the propellant and can affect product delivery.) Depress the actuator and dispense a small amount of foam (not more than a dollop the size of a golf ball).

Apply foam to the affected areas.

Avoid contact with the eyes.

Massage the dispensed foam into the affected areas and wait 1 to 2 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 2 times daily, as directed by a physician.

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 any of these side effects or any other side effects bother you or do not go away:

• Dry skin.
• Itching.
• Skin irritation.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Rosula may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.