Finacea is supplied as a topical gel or foam and contains azelaic acid, a naturally occurring acid. Azelaic acid helps the skin to renew itself more quickly and therefore reduces pimple and blackhead formation. It also helps to kill the bacteria that cause acne and rosacea.

Finacea is used to treat mild to moderate rosacea (a skin condition marked by red eruptions, usually on the cheeks and nose.) This medicine may not be effective in treating skin redness.

Finacea Gel contains 15% azelaic acid in an aqueous gel base. Finacea foam contains 15% azelaic acid in a white to off-white emulsion and is supplied in a pressurized aluminum can.

Avoid getting Finacea in your eyes, nose, mouth, rectum, or vagina. Do not use on sunburned, windburned, dry, chapped, irritated, or broken skin. Wait until these conditions have healed before using this medication. Do not cover the area after applying Finacea. Doing so could cause too much medicine to be absorbed by your body and could be harmful.

It may take up 4 weeks or longer before your symptoms improve. Keep using Finacea as directed and tell your doctor if your symptoms do not improve after 12 weeks of treatment.

If you have excessive burning, dryness, or irritation, ask your doctor about applying this medicine just once daily.

Apply Finacea exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not take by mouth. Topical medicine is for use only on the skin.

Wash your hands before and after applying this medicine.

Shake the foam well before each use.

Clean the affected area with a mild soap or a soap-free cleansing lotion and pat dry with a soft towel. Apply the medication as directed.

Do not apply to sunburned, windburned, dry, chapped, irritated, or broken skin.

Do not cover the treated skin area with a bandage unless your doctor tells you to.

Your symptoms may not improve for up to 4 weeks. Call your doctor if your symptoms do not improve after 12 weeks of treatment.

Tell your doctor if you have excessive burning, dryness, or skin irritation.

Store at room temperature away from moisture and heat. Throw away the foam 8 weeks after opening.

Finacea foam is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Usual Adult Dose for Acne Rosacea:

15% Gel/Foam Formulations: Apply a thin layer to the affected area(s) 2 times a day

Comments:
-The affected area(s) should be gently washed and dried before application with a very mild soap or soapless cleansing lotion.
-This drug should be gently but thoroughly massaged into the affected areas in the morning and evening.
-Patients may apply cosmetics once the treatment has dried.
-Patients should be reassessed if improvement is not observed after completing 12 weeks of treatment.
-For patients using foam formulations, the smallest amount of foam should be used to adequately cover the affected area(s) with a thin layer.

Use: Topical treatment of the inflammatory papules and pustules of mild to moderate rosacea

You should not use Finacea if you are allergic to azelaic acid or propylene glycol.

Tell your doctor if you have ever had asthma.

Tell your doctor if you are pregnant or breastfeeding.

If you breastfeed, avoid applying this medicine to your nipple area.

Finacea is not approved for use by anyone younger than 18 years old.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

Rinse with water if this medicine gets in your eyes, nose, mouth, rectum, or vagina. Call your doctor if you have ongoing irritation after getting this medicine in your eyes.

Avoid using other medications on the areas you treat with Finacea unless your doctor tells you to.

Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime.

Your doctor may recommend avoiding spicy foods, hot foods or drinks, alcoholic beverages and other foods or beverages that may cause flushing or redness of the skin during treatment with this medicine.

Get emergency medical help if you have signs of an allergic reaction to Finacea: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

• severe burning, stinging, or warmth;

• severe itching or tingling;

• severe redness, dryness, peeling, or other irritation;

• changes in skin color; or

• new or worsening breathing problems.

Common Finacea side effects may include:

• pain, burning, stinging, or tingling;

• dry or scaly skin; o

• itching or other 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.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.