FDA label 08385d6c-6e21-4d5f-8aaf-da65ec99e079

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: e76e95d0-e666-48c4-8ec4-a65215bf8512
SPL ID: 08385d6c-6e21-4d5f-8aaf-da65ec99e079
Version: 2
Effective date: 2019-11-05
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:52:20

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		08385d6c-6e21-4d5f-8aaf-da65ec99e079	id
spl set id		e76e95d0-e666-48c4-8ec4-a65215bf8512	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 or sensitive to any of the ingredients listed. When using this product avoid contact in or near eyes and mouth (oral mucosa). In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation, rash or other allergic reaction develops.

Reported adverse events (FAERS/openFDA)#

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