FDA.reportPublic FDA data

FDA label 1b8d0909-b38a-1794-e063-6294a90a2437

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
82872a07-04db-5263-e053-2a91aa0aa2c2
SPL ID
1b8d0909-b38a-1794-e063-6294a90a2437
Version
6
Effective date
2024-06-23
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:45

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. Ask a doctor before use in case of : Deep puncture wounds, Animal bites, Or serious burns Do not use : if you are allergic to any of the ingredients, in the eyes, over large areas of the body, longer than 1 week unless directed by a doctor Stop use and ask a doctor if : the condition worsens, or if symptoms persist for more than 7days or clear up and occur again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

Reported adverse events (FAERS/openFDA)#

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