FDA label 4135e2f1-2c9c-40f9-8455-c6241bb5cddd

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: a44fd2c9-175a-46d8-838d-1ed1495a12c1
SPL ID: 4135e2f1-2c9c-40f9-8455-c6241bb5cddd
Version: 10
Effective date: 2011-02-16
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 06:31:25

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		4135e2f1-2c9c-40f9-8455-c6241bb5cddd	id
spl set id		a44fd2c9-175a-46d8-838d-1ed1495a12c1	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

From Warnings Section of Carton Label: Warnings For external use only. ______________________________ Ask a doctor before use on children under 2 years of age ____________________________________ When using this product avoid contact with the eyes ____________________________________ Stop use and consult a doctor if - Irritation occurs - you do not notice improvement within 4 weeks ____________________________________ KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN If accidental ingestion occurs, immediately contact a physician, emergency medical facility or Poison Control Center for help.

Reported adverse events (FAERS/openFDA)#

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