FDA.reportPublic FDA data

Leader Dry Eye Relief Eye Drops (PLD)

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER | KC Pharmaceuticals, Inc.
Effective date
2026-08-17
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-20 01:01:03

Label at a glance#

ProductLeader Dry Eye Relief Eye Drops
Active ingredientGLYCERIN, HYPROMELLOSE, UNSPECIFIED, POLYETHYLENE GLYCOL 400
Label structure10 sections

Dosage and administration

Sequence 5

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 1%

OTC - PURPOSE SECTION

​Purpose

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant

INDICATIONS & USAGE SECTION

​Uses

  • for the temporary relief of burning and irritation due to dryness of the eye
  • for protection against further irritation

WARNINGS SECTION

​Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use this productif solution changes color or becomes cloudy

OTC - WHEN USING SECTION

When using this product

  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • remove contact lens before using

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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

OTHER SAFETY INFORMATION

Other information

Store at 15 o-30 oC (59 o-86 oF)

INACTIVE INGREDIENT SECTION

​Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic 

Directions

RECENT MAJOR CHANGES SECTION

Sequence 5

Leader Dry Eye Relief Eye Drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Dry Eye Relief Eye Drops 15mLLeader Dry Eye Relief Eye Drops 15mL

Leader Dry Eye Relief Eye Drops 15mL twin pk

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Dry Eye Relief Eye Drops 15mL twin pkLeader Dry Eye Relief Eye Drops 15mL twin pk

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295137064GTIN-13: 0096295137064
EAN-13: 0096295137064
GTIN-12: 096295137064
UPC-A: 096295137064
GTIN storage (14 digits): 00096295137064		KC DL - Leader Dry Eye Relief Eye Drops (May 2022 image update).jpg
BarcodeEAN-130096295137071GTIN-13: 0096295137071
EAN-13: 0096295137071
GTIN-12: 096295137071
UPC-A: 096295137071
GTIN storage (14 digits): 00096295137071		KC DL - Leader Dry Eye Relief Eye Drops 15mL twin pk (2022 image update).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0502-1ML - Milliliter70000-05021f203b31-da5d-4e94-9c33-96546f6e91ec12020-02-13
70000-0502-2ML - Milliliter70000-0502cf12542e-c79c-433c-bb69-279435fa1c4812020-04-20

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-050270000-0502-1, 70000-0502-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DEXTROSEIY9XDZ35W2IACT
EDETATE DISODIUM7FLD91C86KIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72026-03-03full-release2026-06-01 01:49:56

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 Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
ndc (package): 70000-0502-1
ndc (package): 70000-0502-2
ndc (product): 70000-0502
ndc11 (package): 70000050202
ndc11 (package): 70000050201
spl id: 5944f7bf-c84b-497f-e063-6394a90aed1f
spl set id: 2ded4bda-b3c3-4521-8701-5c8446fd148b

Reported adverse events (FAERS/openFDA)#

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