Home FDA labels 8effb720-d9f5-2961-e053-2a95a90ac10f FDA label 8effb720-d9f5-2961-e053-2a95a90ac10f 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 39a13f27-8e3e-4085-8972-a0dd17612cd2
SPL ID 8effb720-d9f5-2961-e053-2a95a90ac10f
Version 4
Effective date 2019-07-31
Source export date 2026-09-28
Source partition 12
Source file https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:22:38
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.
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 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 pain irritation or rash in the ear had ear surgery dizziness Stop use and ask a doctor if irritation (too much burning) or pain occurs
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.