FDA label 57b12446-f4ca-c51c-e063-6394a90a1133

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: 5b4e8ef1-2984-cf1c-e053-2a91aa0aa771
SPL ID: 57b12446-f4ca-c51c-e063-6394a90a1133
Version: 3
Effective date: 2026-07-28
Source export date: 2026-10-12
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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:29:56

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		57b12446-f4ca-c51c-e063-6394a90a1133	id
spl set id		5b4e8ef1-2984-cf1c-e053-2a91aa0aa771	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. Avoid contact with the eyes If condition worsens or symptoms persist for more than seven days or clear up and occur again within a few days, stope use of this product and do not begin use of any hydrocortisone product until you have consulted a physician. Do not use for the treatment of diaper rash. Consult a physician. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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