FDA label 77dd0628-f71e-4ce1-ad1e-32402e023587

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: 7ae6baed-616d-4c05-808c-b7230ed47c0a
SPL ID: 77dd0628-f71e-4ce1-ad1e-32402e023587
Version: 1
Effective date: 2018-01-29
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:07:04

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		77dd0628-f71e-4ce1-ad1e-32402e023587	id
spl set id		7ae6baed-616d-4c05-808c-b7230ed47c0a	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. Avoid Contact with Eyes • Consult a physician for use in children under 12 kyears of age. • IF PREGNANT OR BREASE - FEEDING, ask a health professional before use • KEEP OUT OF THE REACH OF CHILDREN • In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away. • Caution - Not for prolonged use. If condition persists or a rash develops, discontinue use & consult a health care professional. KEEP OUT OF THE REACH OF CHILDREN

Reported adverse events (FAERS/openFDA)#

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