FDA label b57e668f-cdc3-4103-e053-2a95a90a3dce

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: aaf71a7a-a49d-6697-e053-2995a90aef51
SPL ID: b57e668f-cdc3-4103-e053-2a95a90a3dce
Version: 2
Effective date: 2020-12-02
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:35:22

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		b57e668f-cdc3-4103-e053-2a95a90a3dce	id
spl set id		aaf71a7a-a49d-6697-e053-2995a90aef51	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 fire or flame. Do not apply around eyes. Do not use in ears & mouth. When using this product, avoid contact with eyes. In case of contact flush eyes with water. Stop use and ask a doctor if redness or irritation develope and persist for more than 72 hours. Keep out of reach of children. Children must be supervised in use of this product.

Reported adverse events (FAERS/openFDA)#

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