FDA label b8b9119d-ed4d-4024-a433-e62dcfcc8b48

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: cbe10b90-354e-4396-b878-cff31a4b0e2e
SPL ID: b8b9119d-ed4d-4024-a433-e62dcfcc8b48
Version: 1
Effective date: 2012-10-15
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:32:32

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		b8b9119d-ed4d-4024-a433-e62dcfcc8b48	id
spl set id		cbe10b90-354e-4396-b878-cff31a4b0e2e	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 WHEN USING THIS PRODUCT DO NOT GET INTO EYES. IF CONTACT OCCURS, WINSE THOROUGHLY WITH WATER. STOP USING THIS PRODUCT AND ASK A DOCTOR IF CONDITION WORSENS OR SYMPTOMS PERSIST MORE THAN SEVEN DAYS OR CLEAR UP AND RECUR WITHIN A FEW DAYS. DO NOT USE ON DEEP OR PUNCTURE WOUNDS, ON ANIMAL BITES OR ON SERIOUS BURNS. KEEP OUT OF REACH OF CHILDREN IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Reported adverse events (FAERS/openFDA)#

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