FDA.reportPublic FDA data

Leader Long Lasting Lubricant Eye Drops

Manufacturer
Cardinal Health | KC Pharmaceuticals, Inc.
Effective date
2026-03-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:34:01

Label at a glance#

ProductLeader Long Lasting Lubricant Eye Drops
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Polyethylene glycol 400  0.4%
Propylene glycol   0.3%

OTC - PURPOSE SECTION

Purpose

Polyethylene glycol 400............. Lubricant
Propylene glycol............ Lubricant

INDICATIONS & USAGE SECTION

Uses
• for the temporary relief of burning and irritation due to dryness of the eye

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

Do not use
• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

OTC - WHEN USING SECTION

When using this product
• do not touch the tip of container to any surface to avoid contamination
• replace cap after each use

OTC - STOP USE SECTION

Stop use and ask a doctor if
• you feel eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse or lasts more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

DOSAGE & ADMINISTRATION SECTION

Directions
• Instill 1 or 2 drops in the affected eye(s) as needed
• Children under 6 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Twin sizeTwin size

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0455-1ML - Milliliter70000-0455d888937c-b0b6-4e57-91ab-55b03965438c12019-08-06
70000-0455-2ML - Milliliter70000-0455b4641f73-5bd6-442f-9003-dd1dea25a77c12020-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-045570000-0455-1, 70000-0455-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
ZINC CHLORIDE86Q357L16BIACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4cb883b9-6b16-02cc-e063-6394a90add2a0a7c0f59-dd38-4dba-bd04-af1ec75d65692026-03-10WarningsExact identifier
spl set id: 0a7c0f59-dd38-4dba-bd04-af1ec75d6569

Reported adverse events (FAERS/openFDA)#

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