Leader Artificial Tears 15 mL

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 Artificial Tears 15 mL
Generic name: POLYVINYL ALCOHOL, POVIDONE
Manufacturer: Cardinal Health
Product type: HUMAN OTC DRUG
SPL set ID: 8cccc589-3a8e-baad-e053-2a95a90ab8c7
SPL ID: 5b120e34-0a0e-e1ae-e063-6294a90a15bc
Version: 6
Effective date: 2026-09-09
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 05:19:52

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 Artificial Tears 15 mL	openfda.brand_name
generic name		POLYVINYL ALCOHOL, POVIDONE	openfda.generic_name
manufacturer name		Cardinal Health	openfda.manufacturer_name
ndc	package	70000-0011-1	openfda.package_ndc
ndc	product	70000-0011	openfda.product_ndc
ndc11	package	70000001101	derived:openfda.package_ndc
rxcui		598050	openfda.rxcui
spl id		5b120e34-0a0e-e1ae-e063-6294a90a15bc	id
spl set id		8cccc589-3a8e-baad-e053-2a95a90ab8c7	set_id
unii		532B59J990	openfda.unii
unii		FZ989GH94E	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 this product if solution changes color or becomes cloudy When using this product remove contact lens before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed. Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours Keep out of the reach of children. if accidentally swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.

Reported adverse events (FAERS/openFDA)#

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