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
2026-11-06
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/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:28:05

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.