FDA label 84c00272-163e-4aa1-8625-c2afed560dbb

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
aa85b56c-da8c-47db-bda4-db4d05788721
SPL ID
84c00272-163e-4aa1-8625-c2afed560dbb
Version
4
Effective date
2011-06-02
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:27

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

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, patients should immediately flush the eye with copious quantities of water and seek medical advice.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS In clinical trials, the following local adverse reactions were reported at some point during treatment. Adverse Experience Males Females Burning 64% 78% Pain 50% 72% Inflammation 71% 63% Erosion 67% 67% Itching 50% 65% Reports of burning and pain were more frequent and of greater severity in women than in men. Adverse effects reported in less than 5% of the patients included pain with intercourse, insomnia, tingling, bleeding, tenderness, chafing, malodor, dizziness, scarring, vesicle formation, crusting edema, dryness/peeling, foreskin irretraction, hematuria, vomiting and ulceration.

adverse reactions table

<table width="60%"> <col width="25%"/> <col width="17%"/> <col width="18%"/> <thead> <tr> <th align="center" styleCode="Botrule Toprule " valign="middle"> <content styleCode="bold">Adverse Experience</content> </th> <th align="center" styleCode="Botrule Toprule " valign="middle"> <content styleCode="bold">Males</content> </th> <th align="center" styleCode="Botrule Toprule " valign="middle"> <content styleCode="bold"> Females</content> </th> </tr> </thead> <tbody> <tr> <td align="center" styleCode="Toprule " valign="middle"> <paragraph>Burning</paragraph> </td> <td align="center" styleCode="Toprule " valign="middle"> <paragraph>64%</paragraph> </td> <td align="center" styleCode="Toprule " valign="middle"> <paragraph>78%</paragraph> </td> </tr> <tr> <td align="center" valign="middle"> <paragraph>Pain</paragraph> </td> <td align="center" valign="middle"> <paragraph>50%</paragraph> </td> <td align="center" valign="middle"> <paragraph>72%</paragraph> </td> </tr> <tr> <td align="center" valign="middle"> <paragraph>Inflammation</paragraph> </td> <td align="center" valign="middle"> <paragraph>71%</paragraph> </td> <td align="center" valign="middle"> <paragraph>63%</paragraph> </td> </tr> <tr> <td align="center" valign="middle"> <paragraph>Erosion</paragraph> </td> <td align="center" valign="middle"> <paragraph>67%</paragraph> </td> <td align="center" valign="middle"> <paragraph>67%</paragraph> </td> </tr> <tr> <td align="center" styleCode="Botrule " valign="middle"> <paragraph>Itching</paragraph> </td> <td align="center" styleCode="Botrule " valign="middle"> <paragraph>50%</paragraph> </td> <td align="center" styleCode="Botrule " valign="middle"> <paragraph>65%</paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.