IMPORTANT SAFETY INFORMATION

What is Finacea Foam?

Finacea^® (azelaic acid) Foam is a prescription medicine used on the skin (topical) to treat the inflammatory papules (raised spots) and pustules (pimple-like bumps) of mild to moderate rosacea. The safety and efficacy of Finacea Foam have not been established in pediatric patients.

What should I tell my healthcare provider if I have CHANGES IN MY SKIN COLOR during use of Finacea Foam?

Report abnormal changes in skin color to your healthcare provider. There have been isolated reports of loss of skin color (hypopigmentation) after the use of azelaic acid (the active ingredient in Finacea Foam). If you have a dark complexion, your healthcare provider will monitor you for early signs of loss of skin color.

What should I AVOID when using Finacea Foam?

• Avoid contact with the eyes, mouth, vagina, and other mucous membranes. Azelaic acid has been reported to cause irritation of the eyes. If Finacea Foam does come in contact with the eyes, wash the eyes with large amounts of water, and consult your healthcare provider if eye irritation persists.
• Avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C). The propellant in Finacea Foam is flammable.
• Avoid the use of tight dressings or wrappings where you apply Finacea Foam.
• Avoid use of alcoholic cleansers, tinctures and astringents, abrasives, and peeling agents.

How should I use Finacea Foam?

• Shake well before use. For topical use only.
• Before applying Finacea Foam, cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel.
• Apply Finacea Foam twice daily and use continuously over 12 weeks.
• Wash hands immediately following application of Finacea Foam.
• Cosmetics may be applied after the application of Finacea Foam has dried.
• If allergic reactions occur, discontinue use and consult your healthcare provider.
• Discard product 8 weeks after opening.

What are the possible side effects of Finacea Foam?

The most common side effects occurring at the local site include:

• Pain (described as burning, stinging, "pins and needles," and/or tenderness)
• Itching
• Dryness
• Redness

These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

Where do I learn more?

This summary does not include all the information about Finacea Foam. Read the information that comes with your prescription every time you have a prescription filled. Talk to your healthcare provider or pharmacist about this information. Your healthcare provider is the best person to help you decide if Finacea Foam is right for you.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

You may also report side effects to LEO Pharma Inc. at 1-877-494-4536, option 1, or email to usdrugsafety@leo-pharma.com.

Please click here for the full Prescribing Information.