Azelex (for the skin) is used to pimples caused by rosacea. Azelex may not be effective in treating skin redness.

Azelex may also be used for purposes not listed in this medicine guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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.

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

You should not use Azelex 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.

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 Azelex 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 Azelex 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 Azelex.

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

This medicine may cause serious side effects. 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 side effects of Azelex 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.