podofilox
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.