FDA label 03c53289-95c0-482e-8012-bffe3c5927a5

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
e304569e-575f-498c-bc65-c9336a0bd6ea
SPL ID
03c53289-95c0-482e-8012-bffe3c5927a5
Version
1
Effective date
2019-11-01
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:50

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 breast-feeding, 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 mechanical device or applicator Stop use and ask a doctor if Condition worsens, symptoms persist for more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked a doctor 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

Reported adverse events (FAERS/openFDA)#

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