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

Azelaic acid topical 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.

Azelaic acid topical 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:

20% Cream Formulations: Apply a thin layer to the affected area(s) 2 times a day

Comments:
-The affected area(s) should be gently washed and patted dry before application.
-This drug should be gently but thoroughly massaged into the affected area(s) in the morning and evening.
-The duration of therapy is based upon the patient and the severity of the acne.
-Improvement in patients with inflammatory lesions usually occurs within 4 weeks.

Use: Topical treatment of mild-to-moderate inflammatory acne vulgaris

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

Usual Pediatric Dose for Acne:

12 years and older:
20% Cream Formulations: Apply a thin layer to the affected area(s) 2 times a day

Comments:
-The affected area(s) should be gently washed and patted dry before application.
-This drug should be gently but thoroughly massaged into the affected area(s) in the morning and evening.
-Improvement in patients with inflammatory lesions usually occurs within 4 weeks.

Use: Topical treatment of mild-to-moderate inflammatory acne vulgaris

You should not use azelaic acid topical 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze. Dispose of the gel pump and the foam 8 weeks after opening the container.

Azelaic acid foam is flammable, keep it away from flames and extreme heat. Do not puncture or incinerate the azelaic acid foam container.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

If you have rosacea, you should avoid foods and drinks that cause you to flush or blush. These may include alcoholic drinks, spicy foods, and hot drinks such as coffee and tea.

If you have acne, continue your normal diet unless your doctor tells you otherwise.

Rinse with water if azelaic acid topical 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 azelaic acid topical 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 azelaic acid topical.

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 azelaic acid topical 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.