FDA label ee8665e4-eb23-2f51-e053-2995a90a8770

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: fca38e50-bb06-4b87-b201-f8fc01556d66
SPL ID: ee8665e4-eb23-2f51-e053-2995a90a8770
Version: 3
Effective date: 2022-11-28
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:09:39

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		ee8665e4-eb23-2f51-e053-2995a90a8770	id
spl set id		fca38e50-bb06-4b87-b201-f8fc01556d66	set_id

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 the treatment of diaper rash. Ask a doctor For external genital itching if you have a vaginal discharge. Ask a doctor When using this product Avoid contact with the eyes Do not begin use of any other Hydrocortisone product unless you have asked a doctor For external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into 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 • KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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