VEREGEN Ointment Ref.[11070] Active ingredients: Sinecatechins

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

1.1 Indication

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

1.2 Limitations of Use

The safety and effectiveness of Veregen have not been established for treatment beyond 16-weeks or for multiple treatment courses.

The safety and effectiveness of Veregen in immunosuppressed patients have not been established.

2. Dosage and Administration

2.1 General Dosing Information

Veregen is to be applied three times per day to all external genital and perianal warts.

Apply about an 0.5 cm strand of the Veregen 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. Patients should wash their hands before and after application of Veregen.

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

Veregen is not for ophthalmic, oral, intravaginal, or intra-anal use.

2.2 Treatment Period

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.

16.2. Storage and Handling

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 THE REACH OF CHILDREN.

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