Leader Preservative-Free Ultra Lubricating Eye Drops

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)

Brand name: Leader Preservative-Free Ultra Lubricating Eye Drops
Generic name: POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Manufacturer: Cardinal Health
Product type: HUMAN OTC DRUG
SPL set ID: 2a2aa620-ca63-4698-88fd-fc263b8fa0d1
SPL ID: 21ad0d2c-69b0-b7c3-e063-6294a90aaec0
Version: 8
Effective date: 2024-09-07
Source export date: 2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:53:28

Harmonized routes table
Harmonized routes
OPHTHALMIC

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M018	openfda.application_number
brand name		Leader Preservative-Free Ultra Lubricating Eye Drops	openfda.brand_name
generic name		POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	openfda.generic_name
manufacturer name		Cardinal Health	openfda.manufacturer_name
ndc	package	70000-0501-1	openfda.package_ndc
ndc	product	70000-0501	openfda.product_ndc
ndc11	package	70000050101	derived:openfda.package_ndc
rxcui		477589	openfda.rxcui
spl id		21ad0d2c-69b0-b7c3-e063-6294a90aaec0	id
spl set id		2a2aa620-ca63-4698-88fd-fc263b8fa0d1	set_id
unii		6DC9Q167V3	openfda.unii
unii		B697894SGQ	openfda.unii

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 • if this product changes color or becomes cloudy • if you are sensitive to any ingredient in this product When using this product • do not touch the tip of container to any surface to avoid contamination • do not reuse once opened, discard Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours If pregnant or breast-feeding , ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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