Jane S. Ricciuti, RPh, MS


October 23, 2002

In This Article

Dermatologic Agents

(imiquimod) Topical Cream

Manufacturer: 3M Pharmaceuticals

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 9/03/02)

New Indication: Two supplemental indications were approved for Aldara topical cream,

  • Pediatric Indication:

  • -- In the INDICATIONS AND USAGE section, labeling allowing use down to age 12 years:

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

    -- In the Pediatric Use section wording establishing safety and efficacy down to 12 years:

    • Safety and efficacy in patients below the age of 12 years have not been established.

  • In the Information for Patients section, additional information instructing female patients to avoid using the product in the vagina

Dosing: Aldara cream is applied 3 times per week, prior to normal sleeping hours, and left on the skin for 6-10 hours. Following the treatment period, the cream should be removed by washing the treated area with mild soap and water. Aldara treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks.

Aldara (imiquimod) Topical Cream Labeling

Aldara (imiquimod) Topical Cream


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