FDA label 5c128e0f-8dfb-4c38-9bf8-d8e3d8ad826d

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: b640fa53-80d6-4eb9-9994-790a96a166d4
SPL ID: 5c128e0f-8dfb-4c38-9bf8-d8e3d8ad826d
Version: 2
Effective date: 2020-08-25
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:30:28

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		5c128e0f-8dfb-4c38-9bf8-d8e3d8ad826d	id
spl set id		b640fa53-80d6-4eb9-9994-790a96a166d4	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. Flammable. Keep away from fire or flame ---------------------------------------------------------------------------- Do not use • in children less than 2 months of age • on open skin wounds ---------------------------------------------------------------------------- When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. ---------------------------------------------------------------------------- Stop use and ask a doctor if irritation or rash appears and lasts.

Reported adverse events (FAERS/openFDA)#

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