FDA label 0cca45e4-0549-5fbb-e063-6294a90a8098

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: d2183ea0-0bdd-08eb-e053-2995a90ac71c
SPL ID: 0cca45e4-0549-5fbb-e063-6294a90a8098
Version: 5
Effective date: 2023-12-18
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:11

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		0cca45e4-0549-5fbb-e063-6294a90a8098	id
spl set id		d2183ea0-0bdd-08eb-e053-2995a90ac71c	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 Warnings For external use only. _____________________________________ Avoid contact with eyes. _____________________________________ If condition worsens, or if symptoms persist for more than 7 days or clear up and occur agai within a few days, discontinue use of this product and consult a doctor. Do Not Use Do not use on broken or irritated skin. Stop Use Stop use and ask a doctor if skin irritation develops. If pregnant or breastfeeding If pregnant or breastfeeding , ask a health professional before use. Keep out of reach of children Keep out of reach of children , in case of overdose, get medical help or contact a poison control center right away.

Reported adverse events (FAERS/openFDA)#

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