FDA label 71bc118f-2c9c-49a9-bb16-d61a03b12571

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
38443830-b7d8-4028-8878-8a0fde5e888a
SPL ID
71bc118f-2c9c-49a9-bb16-d61a03b12571
Version
1
Effective date
2014-03-11
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:49:44

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 treatment of diaper rash. Consult a doctor. When using this product: avoid contact with eyes, do not exceed the recommended daily dosage unless directed by a doctor, & do not put into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if : bleeding occurs, condition worsens, &/or symptoms persist for more than 7 days or clear up & occur again with a few days. Do not begin use of 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.