FDA label 5117acf0-3ac5-705b-e063-6394a90a6deb

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: ecab59d4-1f09-ef9e-e053-2995a90a0781
SPL ID: 5117acf0-3ac5-705b-e063-6394a90a6deb
Version: 3
Effective date: 2026-05-05
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 05:56:53

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		5117acf0-3ac5-705b-e063-6394a90a6deb	id
spl set id		ecab59d4-1f09-ef9e-e053-2995a90a0781	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

For External use on children under 2 years of age, unless directed by a doctor. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. If swallowed, call a poison control centre or get medical help right away.

Reported adverse events (FAERS/openFDA)#

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