Prior genital wart treatment within 8 weeks

Pregnancy or breast-feeding

Presence of broken or non-intact skin near the wart site or other skin disease at the wart site (e.g., herpes genitalis)

Treatment with systemic steroids, systemic immunomodulators, immunosuppressants, or chemotherapeutic agents within 3 months

Current or prior diagnosis of Bowenoid papulosis, cancer, or pre-cancerous tissue in the genital area

Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts