Veregen™ is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Veregen™ Ointment, 15% is to be applied three times per day to all external genital and perianal warts.

It is recommended to wash the hands before and after application of Veregen™. About a 0.5 cm strand of the Veregen™ Ointment, 15% should be applied to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts.

It is not necessary to wash off the ointment from the treated area prior to the next application.

Treatment with Veregen™ should be continued until complete clearance of all warts, however no longer than 16 weeks.

Local skin reactions (e.g. erythema) at the treatment site are frequent. Nevertheless, treatment should be continued when the severity of the local skin reaction is acceptable.

Veregen™ Ointment, 15% is a brown ointment and is supplied in aluminium tubes containing 15 gram ointment per tube.

Storage Conditions

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

Keep out of reach of children

NDC # 10337-450-15

The VEREGEN trademark is used by Bradley Pharmaceuticals, Inc. under license from MediGene AG.

Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham, Germany. Manufactured for: DOAK DERMATOLOGIC, S A SUBSIDIARY OF BRADLEY PHARMACEUTICALS, INC. 383 Route 46 West Fairfield, NJ 07004 2402 USA. Co-marketed with Kenwood Therapeutics, a division of Bradley Pharmaceuticals, Inc. December 2007. FDA Rev date: 12/19/2007

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