FDA label 55e617e6-5eae-4914-b0f0-f9e80ee9b0e6

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: 5f16010f-e2d3-4d94-b5a3-d6e84197e64b
SPL ID: 55e617e6-5eae-4914-b0f0-f9e80ee9b0e6
Version: 2
Effective date: 2020-07-30
Source export date: 2026-10-12
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/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:26:30

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		55e617e6-5eae-4914-b0f0-f9e80ee9b0e6	id
spl set id		5f16010f-e2d3-4d94-b5a3-d6e84197e64b	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.