FDA label e078e140-0b97-46e9-99c8-de9c5593a5bb

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: ae22a4f1-77bd-4b37-bf3c-24f402e15bf0
SPL ID: e078e140-0b97-46e9-99c8-de9c5593a5bb
Version: 3
Effective date: 2014-10-17
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 02:21:27

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		e078e140-0b97-46e9-99c8-de9c5593a5bb	id
spl set id		ae22a4f1-77bd-4b37-bf3c-24f402e15bf0	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 the mouth or eyes with known sensitivities to any listed ingredients on children under 2 years of age unless directed by a doctor When using this product avoid eye contact. If accidental eye contact occurs, rinse thoroughly with water for 10-15 minutes. Stop use and ask a doctor if rash or irritation occurs, or if no improvement is seen after four weeks. If pregnant/breast-feeding, consult a health professional before using. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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