FDA label 381018d8-7be8-4521-afbb-06965feb99e5

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
5680c7fa-52ed-4d26-93bf-2565c130ed42
SPL ID
381018d8-7be8-4521-afbb-06965feb99e5
Version
2
Effective date
2017-10-16
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:59

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 nursing, ask a health professional before use • Should not be used by patients with a history of hypersensitivity to any of the components of the preparation. When using this product Avoid contact with eyes Do not bandage or wrap the treated are Stop use and ask a physician if Patient sees signs of allergic reaction such as increased redness or itching in case of bleeding if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days before you begin using any other hydrocortisone product children under 2 years of age: consult a doctor Do not use: On deep puncture wounds On animal bites On serious burns Before using any medication, read all label directions.

Reported adverse events (FAERS/openFDA)#

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