FDA label 5a5d0dcd-b17a-86d4-e063-6294a90ac3aa

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
fd6461a5-bb03-4805-ba93-c7b09dfc32c5
SPL ID
5a5d0dcd-b17a-86d4-e063-6294a90ac3aa
Version
3
Effective date
2026-08-31
Source export date
2026-10-27
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/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 20:50:57

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

WARNINGS: For external use only. When using this product avoid contact with the eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any other mechanical device or applicator Stop use and ask doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not suside or if redness, irritation swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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