FDA label fc1eb9dc-e9d3-4eb8-a93e-8d0b50c02b5b

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: 3469a868-fdc6-4423-a8e2-8c64dc6b4c73
SPL ID: fc1eb9dc-e9d3-4eb8-a93e-8d0b50c02b5b
Version: 2
Effective date: 2020-07-09
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:13:48

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		fc1eb9dc-e9d3-4eb8-a93e-8d0b50c02b5b	id
spl set id		3469a868-fdc6-4423-a8e2-8c64dc6b4c73	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 • On children less than 2 months of age. • Avoid contact with broken skin. • Avoid contact with metallic items. -------------------------------------------------------------------------------------------------------- When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. -------------------------------------------------------------------------------------------------------- Stop use and ask a doctor if skin irritation occurs and consult a doctor immediately.

Reported adverse events (FAERS/openFDA)#

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