FDA.reportPublic FDA data

FDA label 3ab5653e-b6d3-2efb-e063-6294a90a366a

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
30d015b6-af52-fefa-e063-6294a90aec66
SPL ID
3ab5653e-b6d3-2efb-e063-6294a90a366a
Version
3
Effective date
2025-07-24
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:39

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

For external use only including the skin of the anal canal. When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if condition worsens or does not improve within seven days, bleeding occurs, an allergic reaction develops, the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

Reported adverse events (FAERS/openFDA)#

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