FDA label 6986cd5a-854f-18de-e053-2a91aa0a297e

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: 2e3264e8-e167-38a9-e054-00144ff8d46c
SPL ID: 6986cd5a-854f-18de-e053-2a91aa0a297e
Version: 4
Effective date: 2018-04-10
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:11:05

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		6986cd5a-854f-18de-e053-2a91aa0a297e	id
spl set id		2e3264e8-e167-38a9-e054-00144ff8d46c	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For external use only. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician. Do not apply to wounds or damaged skin. Do not bandage tightly. If pregnant or breast feeding, contact physician prior to use.

warnings and cautions

WARNINGS AND PRECAUTIONS

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Anaphylaxis and Angioedema Withdrawal Precipitated Seizure, Status Epilepticus Suicidal Behavior and Ideation Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age) Sudden and Unexplained Death in Patients with Epilepsy 1. Clinical Trials Experience

Reported adverse events (FAERS/openFDA)#

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