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
2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:38:52

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.