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 Topical Solution 0.5% is indicated for the topical treatment of external genital warts (Condyloma acuminatum). This product is not indicated in the treatment of perianal or mucous membrane warts (see PRECAUTIONS ). Diagnosis Although genital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma (so-called "Bowenoid papulosis") is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus but should not be treated with Podofilox Topical Solution 0.5%.

Warnings

WARNINGS Correct diagnosis of the lesions to be treated is essential. See the " Diagnosis " subsection of the INDICATIONS AND USAGE statement. Podofilox Topical Solution 0.5% is intended for cutaneous use only. Avoid contact with the eye. If eye contact occurs, patient should immediately flush the eye with copious quantities of water and seek medical advice.