FDA.reportPublic FDA data

FDA label 2268f3c7-014a-c025-e063-6294a90a5fb6

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
227b652e-f251-9fac-e063-6294a90a8480
SPL ID
2268f3c7-014a-c025-e063-6294a90a5fb6
Version
2
Effective date
2024-09-18
Source export date
2026-11-06
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:53:02

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For external use only When using this product do not use more than directed unless told to do so by a doctor do not put directly in the rectum by using fingers or any mechanical device or applicator Stop use and ask doctor if rectal bleeding occurs condition worsens or does not improve within 7 days Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

For external use only

Reported adverse events (FAERS/openFDA)#

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