FDA label f04a5c7a-44c3-2b1b-e053-2a95a90ab24c

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: f04a5c7a-44d2-2b1b-e053-2a95a90ab24c
SPL ID: f04a5c7a-44c3-2b1b-e053-2a95a90ab24c
Version: 1
Effective date: 2022-12-20
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:02:25

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		f04a5c7a-44c3-2b1b-e053-2a95a90ab24c	id
spl set id		f04a5c7a-44d2-2b1b-e053-2a95a90ab24c	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

W arnings Flammable: Keep away from fire or flame Do not use in the eyes Ask a doctor before use if you have • ear drainage or discharge • ear pain, irritation or rash in the ear • dizziness • recently had ear surgery Stop use and ask a doctor if irritation (too much burning) or pain occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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