FDA.reportPublic FDA data

FDA label 3ec7e573-e787-45fc-882c-ddc8d9a107cc

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
c75c13c2-a43b-428a-9e16-8859b2cd8fe3
SPL ID
3ec7e573-e787-45fc-882c-ddc8d9a107cc
Version
2
Effective date
2023-01-09
Source export date
2026-08-01
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:15:47

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 • 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 a doctor if • rectal bleeding occurs • condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.