FDA label fde1e615-da47-4211-8bee-bc8707e984ed

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: 5a947376-075d-4c70-abc0-0dd503e8f7f2
SPL ID: fde1e615-da47-4211-8bee-bc8707e984ed
Version: 2
Effective date: 2021-08-26
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:42:41

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		fde1e615-da47-4211-8bee-bc8707e984ed	id
spl set id		5a947376-075d-4c70-abc0-0dd503e8f7f2	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 if you are allergic to any of the ingredients When using this product • Avoid getting into the eyes. • In case of eye contact, immediately flush eyes thoroughly with water. Stop use and ask a doctor if • Irritation or redness develops • Conditions persist for more than 72 hours • Redness is present Keep out of reach of children. In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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