Azelaic Acid Topical gel

What is this medicine?

AZELAIC ACID (ay ze LAY ik AS id) is used on the skin to treat mild to moderate rosacea.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• herpes or cold sores
• an unusual or allergic reaction to propylene glycol, azelaic acid, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for external use only. Do not take by mouth. Follow the directions on the prescription label. Wash your hands before and after use. Make sure the skin is clean and dry. Apply just enough gel to cover the affected area. Rub in gently but completely. Keep the gel away from the eyes, mouth, and other areas of sensitive skin. If accidental contact occurs, large amounts of water should be used to rinse the affected area. If your eyes are still irritated, contact your doctor or health care professional. Do not place a bandage, wrap, or dressing on top of skin where azelaic acid has been applied. If you are using other topical medicines, apply them at different times of the day.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

Interactions are not expected. Do not use any other skin products without telling your doctor or health care professional.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Contact your doctor or health care professional if your skin condition gets worse or does not get better in the first 4 weeks or if the medicine causes too much redness, dryness, or peeling of skin. It may take longer than 4 weeks before you see the full effect.

Small amounts of water based cosmetics may be used while using this medicine. Apply cosmetics after this medicine has dried.

Avoid eating or drinking foods or beverages that may make redness, flushing, and blushing worse. Examples include spicy foods, alcohol, hot coffee, or hot tea.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• lightening of the treated areas (in patients with dark complexions)
• severe burning, itching, crusting, or swelling of the treated areas

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dry skin
• mild burning, itching, or stinging
• reddening of the skin
• skin peeling

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.