FDA label f163640d-99e3-9d0c-e053-2995a90a0ee4

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
145d3310-09e4-46c4-8142-a9bbebcbc5bc
SPL ID
f163640d-99e3-9d0c-e053-2995a90a0ee4
Version
8
Effective date
2023-01-03
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:02:40

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 . Avoid contact with the eyes. Do not use and consult a doctor for the treatment of diaper rash, if you have a vaginal discharge. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor. Do not exceed the recommended daily dosage unless directed by the doctor. In case of bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Reported adverse events (FAERS/openFDA)#

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