FDA label b319f5bd-2169-c8eb-e053-2995a90a03d3

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: b319f5bd-2168-c8eb-e053-2995a90a03d3
SPL ID: b319f5bd-2169-c8eb-e053-2995a90a03d3
Version: 1
Effective date: 2020-11-02
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 05:13:51

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		b319f5bd-2169-c8eb-e053-2995a90a03d3	id
spl set id		b319f5bd-2168-c8eb-e053-2995a90a03d3	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 heat or flame. Do not use Do not use on open skin wounds. in children less than 2 mouths of age. When using this product When using this product, keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use Stop ue and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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