podofilox

FDA Drug Profile — Condylox

Drug Details

Generic Name
podofilox
Brand Names
Condylox
Application Number
NDA020529
Sponsor
Allergan, Inc.
NDC Codes
1
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
PODOFILOX

Indications and Usage

INDICATIONS AND USAGE Podofilox gel is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with podofilox gel.

Warnings

WARNINGS Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of the INDICATIONS AND USAGE section. Podofilox gel is intended for cutaneous use only. Avoid contact with the eyes. If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice. Drug Product is Flammable. Keep Away from Open Flame.