FDA label 21f4b05f-2bd6-4298-adb8-b8eae52ffadf

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
affc1058-7355-4486-8b65-378fea6f9454
SPL ID
21f4b05f-2bd6-4298-adb8-b8eae52ffadf
Version
12
Effective date
2022-10-05
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:02

Warnings cross-check#

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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 0.5% solution 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><col width="137"/><col width="49"/><col width="63"/><tbody><tr><td align="center"> <content styleCode="bold">Adverse Experience</content></td><td align="center"> <content styleCode="bold">Males</content></td><td align="center"> <content styleCode="bold">Females</content></td></tr><tr><td align="center"> Burning</td><td align="center"> 64%</td><td align="center"> 78%</td></tr><tr><td align="center"> Pain</td><td align="center"> 50%</td><td align="center"> 72%</td></tr><tr><td align="center"> Inflammation</td><td align="center"> 71%</td><td align="center"> 63%</td></tr><tr><td align="center"> Erosion</td><td align="center"> 67%</td><td align="center"> 67%</td></tr><tr><td align="center"> Itching</td><td align="center"> 50%</td><td align="center"> 65%</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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