FDA label 00504ece-a580-46df-be5d-9848b6874370

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
9f0a6c2d-82fc-4972-8b97-dd445a1f8e2e
SPL ID
00504ece-a580-46df-be5d-9848b6874370
Version
3
Effective date
2021-10-20
Source export date
2026-10-12
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/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:04:26

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 children under 2 years of age • if you have a vaginal discharge • for the treatment of diaper rash Ask a doctor before use if you have • external genital or feminine itching • external anal itching • bleeding When using this product • avoid contact with eyes • do not exceed the recommended daily dosage unless directed by a doctor • do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and do not begin use of any other hydrocortisone product

Reported adverse events (FAERS/openFDA)#

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