FDA label 02e79817-5a4a-a88d-e063-6294a90a5a52

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
8ee7a62a-7724-21e9-e053-2995a90a4501
SPL ID
02e79817-5a4a-a88d-e063-6294a90a5a52
Version
6
Effective date
2023-08-14
Source export date
2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:20:58

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 for the treatment of diaper rash with any other Hydrocortisone product unless you have consulted a doctor if you have a vaginal discharge, consult a doctor When using this product avoid contact with eyes do not put this product into rectum by using fingers, mechanical device or applicator do not exceed recommended daily dosage unless directed by a doctor Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product rectal bleeding occurs

Reported adverse events (FAERS/openFDA)#

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