FDA label b609c8b9-7a62-44fc-e053-2995a90a7c26

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: b609c8b9-7a61-44fc-e053-2995a90a7c26
SPL ID: b609c8b9-7a62-44fc-e053-2995a90a7c26
Version: 1
Effective date: 2020-06-15
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 05:52:03

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		b609c8b9-7a62-44fc-e053-2995a90a7c26	id
spl set id		b609c8b9-7a61-44fc-e053-2995a90a7c26	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 Stop use and consult a doctor if symptoms worsen or persist for more than 7 days. Do not use near the eyes, mouth or other mucous membranes if allergic to any ingredients or if irritation develops If pregnant or breast-feeding , ask a healthcare professional before use. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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