FDA.reportPublic FDA data

FDA label 8b0a5d5f-6228-484e-af02-755bfa23bf56

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
c9f49a26-c7b7-4886-9a44-ea6982a37862
SPL ID
8b0a5d5f-6228-484e-af02-755bfa23bf56
Version
1
Effective date
2021-08-09
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:43:22

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. Do not use in the genital area if you have a vaginal discharg. Consult a doctor. for the treatment of diaper rash. Consult a doctor When using this product avoid contact with the eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsen, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor rectal bleeding occurs

Reported adverse events (FAERS/openFDA)#

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