FDA.reportPublic FDA data

Dry eye relief

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Effective date
2025-09-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:14:31

Label at a glance#

ProductDry eye relief
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure13 sections

Indications and uses

▪ for the temporary relief of burning and irritation due to dryness of the eye ▪ for use as a protectant against further irritation or to relieve dryness of the eye

Dosage and administration

▪ shake well before using ▪ put 1 or 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients

Purpose

Polyethylene Glycol 400 0.4%          

Lubricant

Propylene Glycol 0.3%

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of burning and irritation due to dryness of the eye
  • for use as a protectant against further irritation or to relieve dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

  • do not touch 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 experience any of the following:

  • you feel eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed

Other information

OTHER SAFETY INFORMATION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

 boric acid, edetate disodium , potassium chloride, mangnesium chloride , sodium chloride, sodium borate , purified water.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

.

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT

Do not use if tape seals on carton top and bottom flaps are damaged or missing.

*This product is not manufactured or distributed by Alcon, Inc., owner of the registered trademark Systane® Lubricant Gel Drops.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-9313

Made in India

100% Money back Guarantee

Return to place of purchase if not satisfied.

Code: MH/DRUGS/28-KD/283

CIN 5698394

REV. 2/21

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER®

NDC 70000-0088-1

Sterile

Dry Eye Relief

Polyethylene Glycol 400, 0.4%

Propylene Glycol, 0.3%

Lubricant

0.33 FL OZ (10 mL)

0.4% / 0.3% bottle label
0.4% / 0.3% bottle label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER®

NDC 70000-0088-1

Sterile

Dry Eye

Relief

Polyethylene Glycol 400, 0.4%

Propylene Glycol, 0.3%

Lubricant

Moisturizes Dry Eyes

Actual Bottle Size on Side Panel

COMPARE TO SYSTANE® LUBRICANT GEL DROPS active ingredients*

100% Money Back Guarantee

0.33 FL OZ (10 mL)

0.4% / 0.3% carton
0.4% / 0.3% carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelPSN4
895753polyethylene glycol 400 0.004 MG/MG / propylene glycol 0.003 MG/MG Ophthalmic GelSCD4
895753polyethylene glycol 400 0.4 % / propylene glycol 0.3 % Ophthalmic GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0088-12025-09-22C16284748780-11030e365-6347-111a-e063-dadaa90a10e2Sterile Dry eye Relief
70000-0088-12024-01-30C16284748780-11030e365-6347-111a-e063-dadaa90a10e2Sterile Dry eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0088-1Dry eye relief10 mL in 1 BOTTLE, DROPPERGEL104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0088-1ML - Milliliter70000-0088c4379034-b4b4-4e17-a594-325feb0e575012022-02-07

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-008870000-0088-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
EDETATE DISODIUM7FLD91C86KIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CHLORITEG538EBV4VFIACT
ZINC CHLORIDE86Q357L16BIACT
HYDROCHLORIC ACIDQTT17582CBCNTM
SODIUM HYDROXIDE55X04QC32ICNTM

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
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
ndc (package): 70000-0088-1
ndc (product): 70000-0088
ndc11 (package): 70000008801
spl id: 424cccfb-27a9-43c8-9793-34bc5ddcb882
spl set id: f8da3af5-9172-4023-be82-0fd5bd891616

Reported adverse events (FAERS/openFDA)#

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