FDA.reportPublic FDA data

Leader Eye Wash

Manufacturer
Cardinal Health | KC Pharmaceuticals, Inc. | Bausch & Lomb Incorperated
Effective date
2023-12-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:24

Label at a glance#

ProductLeader Eye Wash
Active ingredientWATER
Label structure9 sections

Indications and uses

washes the eye to help relieve irritation discomfort burning stinging itching by removing loose foreign material air pollutants (smog or pollen) chlorinated water

Dosage and administration

For use with nozzle applicator. flush the affected eye(s) as needed control the rate of flow of solution by pressure on the bottle do not touch dropper tip to eye When using an eye cup rinse the cup with Eye Wash Solution immediately before each use avoid contamination of the rim and inside surfaces of the cup fill the cup half full with Eye Wash Solution and apply the cup to affected eye(s), pressing tightly to p...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified water (99.05%)

Purpose

OTC - PURPOSE SECTION

Eyewash

Uses

INDICATIONS & USAGE SECTION

washes the eye to help relieve

  • irritation
  • discomfort
  • burning
  • stinging
  • itching

by removing

  • loose foreign material
  • air pollutants (smog or pollen)
  • chlorinated water

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if you have open wounds in or near the eyes, and get medical help right away
  • if solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

  • remove contact lenses before using
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or persists

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For use with nozzle applicator.

  • flush the affected eye(s) as needed
  • control the rate of flow of solution by pressure on the bottle

do not touch dropper tip to eye

When using an eye cup

  • rinse the cup with Eye Wash Solution immediately before each use
  • avoid contamination of the rim and inside surfaces of the cup
  • fill the cup half full with Eye Wash Solution and apply the cup to affected eye(s), pressing tightly to prevent spillage
  • tilt the head backward. Open eyelids wide and rotate eyeballs to thoroughly wash the eye
  • rinse cup with clean water after each use
  • replace cap after use

Other information

OTHER SAFETY INFORMATION

  • store at 15°-25°C (59°-77°F)
  • keep tightly closed
  • does not contain thimerosal
  • enclosed eyecup is sterile if packaging is intact
  • use before expiration date marked on the carton or bottle

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, sodium borate and sodium chloride.

PRESERVATIVE ADDED: benzalkonium chloride (0.01%)

Questions or comments?

OTC - QUESTIONS SECTION

Toll free Product Information or to Report a Serious Side Effect Associated with use of this product Call: 1-888-527-4276

Leader Eye Wash

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Eye Wash 118 mLLeader Eye Wash 118 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053429water 99.1 % Ophthalmic Irrigation SolutionPSN4
1053429water 991 MG/ML Ophthalmic Irrigation SolutionSCD4
1053429water 99.05 % Ophthalmic Irrigation SolutionSY4
1053429water 99.1 % Ophthalmic Irrigation SolutionSY4
1053429water 99.1 ML per 100 ML Ophthalmic Irrigation SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0018-1Leader Eye Wash118 mL in 1 BOTTLE, DROPPERSOLUTION1184
70000-0018-1Leader Eye Wash1 in 1 BOXSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0018LEADER EYE WASH (PURIFIED WATER) SOLUTION [CARDINAL HEALTH]4Current NDC, Legacy NDC, 2 package rows20240103_8d3ad11f-1945-f838-e053-2995a90a7aa5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0018-1ML - Milliliter70000-00185bce97bd-b3d8-4b1a-bfcd-66761a599b2712020-03-10

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-001870000-0018-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RACTIB
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML · Source PDF

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
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
ndc (package): 70000-0018-1
ndc (product): 70000-0018
ndc11 (package): 70000001801
spl id: 0d37dad1-2198-7c25-e063-6394a90a7eb7
spl set id: 8d3ad11f-1945-f838-e053-2995a90a7aa5

Reported adverse events (FAERS/openFDA)#

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