FDA label 115b638a-0f27-fa4e-e063-6394a90aad77

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: c7b39ecf-d009-4ec8-b4c7-fc6a8b4820c3
SPL ID: 115b638a-0f27-fa4e-e063-6394a90aad77
Version: 12
Effective date: 2024-02-14
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:39:18

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		115b638a-0f27-fa4e-e063-6394a90aad77	id
spl set id		c7b39ecf-d009-4ec8-b4c7-fc6a8b4820c3	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 If pregnant or breastfeeding consult a healthcare professional before use. Do not use on children under 2 years of age unless directed by a doctor When using this product avoid contact with eyes. Use only as directed by a doctor on persons with highly sensitive skin. Stop use and consult a doctor if there is no improvement within 4 weeks irritation occurs Keep out of reach of children. If accidental ingestion occurs, 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.