FDA label 53b60f70-2662-486e-a5d1-a96d3c359ac0

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: 219bbeb0-d2c7-4a7e-9d91-1d7c16bf54e9
SPL ID: 53b60f70-2662-486e-a5d1-a96d3c359ac0
Version: 4
Effective date: 2019-11-23
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:23:44

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		53b60f70-2662-486e-a5d1-a96d3c359ac0	id
spl set id		219bbeb0-d2c7-4a7e-9d91-1d7c16bf54e9	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. DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER. DO NOT USE WITH HEATING PAD OR DEVICE, OR UNDER BANDAGES. DO NOT USE IF PREGNANT OR BREASTFEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE. DO NOT APPLY TO WOUNDS OR DAMAGED SKIN. STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

Reported adverse events (FAERS/openFDA)#

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