FDA label 78e78f82-6420-4685-9d37-588346d05ef9

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: 7c149887-b375-46d4-ac78-4f838464111e
SPL ID: 78e78f82-6420-4685-9d37-588346d05ef9
Version: 2
Effective date: 2012-09-12
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:49:53

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		78e78f82-6420-4685-9d37-588346d05ef9	id
spl set id		7c149887-b375-46d4-ac78-4f838464111e	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

Warning For external use only Do not use near eyes Keep out of reach of children. Discontinue use if irritation and redness develop. If condition persists more than 72 hours, consult a doctor. In case of eye contact, flush with water for 15 minutes. If irritation persists, get medical attention. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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