IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

AZELAIC ACID GEL - TOPICAL

(ay-zeh-LAY-ick acid)

COMMON BRAND NAME(S): Finacea

USES: This medication is used to treat a certain skin condition called rosacea. It helps to reduce the number of inflamed skin lesions.

HOW TO USE: This medication is for use on the skin only. Clean the affected area with a mild soap or soap-free cleanser and pat dry. Apply a thin layer of medication usually twice daily; or use as directed by your doctor. Gently massage it into the affected area. Wash your hands well after using this medication. Make-up may be applied after the medication has dried. Avoid getting any of this medication in the eyes or inside the nose or mouth. If it does get in your eyes, wash your eyes immediately with plenty of water. Call your doctor if eye irritation persists. Do not use large amounts or apply this product more often than directed. Your condition will not clear faster, but the chance for side effects may be increased. Improvement is usually seen within four weeks. However, it may take several weeks of continued use before the full effects of this medication are seen. Do not apply any dressing or covering over the treated area unless you are instructed to do so by your doctor.

SIDE EFFECTS: Burning, stinging, tingling or itching skin may occur during the first few weeks, but then subside as your body adjusts to this medication. Rarely, excessive facial hair growth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. This medication may infrequently cause abnormal changes in skin color (hypopigmentation). Dark-skinned individuals may notice a lightening in skin color. Consult your doctor or pharmacist for advice and report these changes if they occur. Tell your doctor immediately if any of these unlikely but serious side effects occur: worsening of cold sores or fever blisters (oral herpes). Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: worsening of asthma symptoms (e.g., increased trouble breathing, increased use of quick-relief inhalers). An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, persistent itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an allergy to propylene glycol. Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, repeat episodes of cold sores or fever blisters (oral herpes), any allergies. Avoid any foods or liquids that may bring on redness, flushing and blushing of the skin (e.g., spicy foods, alcohol, hot drinks). This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication may pass into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other skin products. Avoid use of skin care products that can cause further irritation (e.g., alcohol-containing cleansers, tinctures, astringents, abrasives and peeling agents). Consult your doctor or pharmacist for details. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 to 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

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Copyright 2004 by First DataBank, Inc.