FDA.reportPublic FDA data

FDA label 486e13f2-9769-a4b6-e063-6394a90a702c

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
1f44e7f0-4bf2-0e08-e063-6394a90a8473
SPL ID
486e13f2-9769-a4b6-e063-6394a90a702c
Version
2
Effective date
2026-01-15
Source export date
2026-11-06
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:10:24

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 using and ask a doctor 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.