FDA.reportPublic FDA data

FDA label efe18723-ca63-3d08-e053-2995a90abe94

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
2c07e434-cea9-4f8b-a0cf-6fc53cf3f2e7
SPL ID
efe18723-ca63-3d08-e053-2995a90abe94
Version
3
Effective date
2022-12-15
Source export date
2026-08-01
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:03:33

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 ​If pregnant or breastfeeding, ask a health professional before use. Do not use in the eyes for diaper rash for external genital or feminine itching if you have a vaginal discharge more than the recommended daily dosage unless directed by a doctor this product in the rectum by using fingers or any other 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 and do not use this or any other hydrocortisone product in case of bleeding when used for anal itching Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.