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Azelaic Acid Gel, 15%

INDICATIONS AND USAGE

Azelaic Acid Gel, 15% is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

Although some reduction of erythema which was present in patients with papules and pustules of rosacea  occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic  beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing.

DOSAGE AND ADMINISTRATION  

A thin layer of Azelaic Acid Gel,15%, should be gently massaged into the affected areas on the face twice daily, in the morning and evening. Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.

INFORMATION FOR PATIENTS

• Azelaic Acid Gel,15%, is to be used only as directed by the physician.
• Azelaic Acid Gel,15%, is for external use only. It is not to be used orally, intravaginally, or for the eyes.
• Cleanse  affected  area(s) with a very mild  soap  or  a  soapless  cleansing  lotion and  pat dry with a soft towel before applying Azelaic Acid Gel, 15%. Avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
• Avoid contact of Azelaic Acid Gel, 15%, with the mouth, eyes and other mucous membranes. If  it  does  come  in  contact  with  the  eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists.
• The hands should be washed following application of Azelaic Acid Gel, 15%.  
• Cosmetics may be applied after Azelaic Acid Gel, 15%, has dried.
• Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of Azelaic Acid Gel, 15%,  usually  during  the  first  few  weeks  of  treatment.  If  irritation  is  excessive  or  persists, use of Azelaic Acid Gel, 15%, should be discontinued, and patients  should  consult  their  
physician.
•  Avoid any foods  and  beverages that might provoke erythema, flushing,  and  blushing (including spicy food, alcoholic beverages, and thermally hot drinks, including hot coffee and tea).
• Patients should report abnormal changes in skin color to their physician.
• Avoid the use of occlusive dressings or wrappings. 


Source: U.S. Food and Drug Administration (FDA)