FDA label b8316ce6-9d48-9e35-e053-2a95a90a1daf

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: a182ff3a-c022-82c2-e053-2995a90af23c
SPL ID: b8316ce6-9d48-9e35-e053-2a95a90a1daf
Version: 5
Effective date: 2021-01-05
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:40:38

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		b8316ce6-9d48-9e35-e053-2a95a90a1daf	id
spl set id		a182ff3a-c022-82c2-e053-2995a90af23c	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 Flammable. Keep away from all flame and heat sources. For external use only. When using this product, avoid contact with eyes. In case of contact flush eyes with water. If irritation or redness & swelling occurs, discontinue use immediately. Do not use if you are allergic to alcohol. Keep out of reach of children. Adults shall assist children in use. Or Attention: 1. Flammable. Keep away from all flame and heat sources. 2. For external use only. Avoid contact with eyes or mouth. If irritation or redness & swelling occurs, discontinue use immediately. Do not use if you are allergic to alcohol. 3. Adults shall assist children in use.

Reported adverse events (FAERS/openFDA)#

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