FDA label d5ae1f55-842c-4193-9bc1-9c341aa0477b

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: b9fe373b-07d4-4659-add7-df3981a0320b
SPL ID: d5ae1f55-842c-4193-9bc1-9c341aa0477b
Version: 3
Effective date: 2020-12-15
Source export date: 2026-10-12
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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:06:54

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		d5ae1f55-842c-4193-9bc1-9c341aa0477b	id
spl set id		b9fe373b-07d4-4659-add7-df3981a0320b	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 • 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.