FDA label 35a9b7db-e775-40b5-b820-1ed9fd336476

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: fca90a2a-3f56-4c47-80d9-054867a8fa50
SPL ID: 35a9b7db-e775-40b5-b820-1ed9fd336476
Version: 1
Effective date: 2020-06-17
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 05:13:46

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		35a9b7db-e775-40b5-b820-1ed9fd336476	id
spl set id		fca90a2a-3f56-4c47-80d9-054867a8fa50	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. Keep away from heat or flame -------------------------------------------------------------------------------------------------------- Do not use • in children less than 2 months of age • on open skin wounds -------------------------------------------------------------------------------------------------------- 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 irritation or rash occurs. These may be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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