FDA label 0f8eebb5-512e-db52-e063-6294a90a9604

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
88e0eb04-b97e-498d-bc6b-add70c4450af
SPL ID
0f8eebb5-512e-db52-e063-6294a90a9604
Version
3
Effective date
2024-01-22
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:15:55

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 the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator Ask a doctor before use if you have a vaginal discharge rectal bleeding diaper rash When using this product consult a doctor before exceeding recommended dosage Stop use and ask a doctor if condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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