INDICATIONS

Aldara 5% cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in individuals 12 years old and above.

DOSAGE AND ADMINISTRATION

Aldara cream is to be applied 3 times per week, prior to normal sleeping hours, and left on the skin for 6-10 hours. Following the treatment period cream should be removed by washing the treated area with mild soap and water. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday; or Tuesday, Thursday, Saturday application prior to sleeping hours. Aldara treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Local skin reactions (erythema) at the treatment site are common. A rest period of several days may be taken if required by the patient’s discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions. The technique for proper dose administration should be demonstrated by the prescriber to maximize the benefit of Aldara therapy. Handwashing before and after cream application is recommended. Aldara 5% cream is packaged in single-use packets which contain sufficient cream to cover a wart area of up to 20 cm2; use of excessive amounts of cream should be avoided. Patients should be instructed to apply Aldara cream to external genital/perianal warts. A thin layer is applied to the wart area and rubbed in until the cream is no longer visible. The application site is not to be occluded.

HOW SUPPLIED

Aldara (imiquimod) cream, 5%, is supplied in single-use packets which contain 250 mg of the cream.

Available as: box of 12 packets NDC 0089-0610-12.

Do not store above 30°C (86°F). Avoid freezing.

Caution: Federal Law prohibits dispensing without prescription.