FDA.reportPublic FDA data

Leader Lubricant Eye Drops Fast-Acting Hydration

Manufacturer
LEADER/Cardinal Health 110, Inc. | KC Pharmaceuticals, Inc.
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:49:51

Label at a glance#

ProductLeader Lubricant Eye Drops Fast-Acting Hydration
Active ingredientPROPYLENE GLYCOL
Label structure9 sections

Indications and uses

for the temporary relief of burning and irritation due to dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye or exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye for use as a lubricant to prevent further irritation or to relieve dryness of the eye

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Propylene glycol 0.6%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of burning and irritation due to dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye or exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for use as a lubricant to prevent 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
  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

store at 59-77ºF (15-25ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, **hydrochloric acid, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride, **sodium hydroxide

**May contain these ingredients to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-527-4276

Leader Lubricant Eye Drops Fast-Acting Hydration 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Lubricant Eye Drops Fast-Acting Hydration 15mLLeader Lubricant Eye Drops Fast-Acting Hydration 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041798propylene glycol 0.6 % Ophthalmic SolutionPSN5
1041798propylene glycol 6 MG/ML Ophthalmic SolutionSCD5
1041798propylene glycol 0.6 % Ophthalmic SolutionSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295144413GTIN-13: 0096295144413
EAN-13: 0096295144413
GTIN-12: 096295144413
UPC-A: 096295144413
GTIN storage (14 digits): 00096295144413		Leader Lub Eye Drops Fast-Acting Hydration 15mL.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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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
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
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0706-1Leader Lubricant Eye Drops Fast-Acting Hydration1 in 1 BOXSOLUTION/ DROPS15
70000-0706-1Leader Lubricant Eye Drops Fast-Acting Hydration15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0706-1ML - Milliliter70000-0706b3f1a1b9-663c-4086-b057-fdf756eb0dcb12025-10-14

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-070670000-0706-1

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
PEG-6 SORBITAN OLEATE58O7V09UCIIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
CASTOR OILD5340Y2I9GIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM BORATE91MBZ8H3QOIACT
POTASSIUM CHLORIDE660YQ98I10IACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-30monthly-update2026-06-03 17:51:10

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
53540823-a6c9-ea46-e063-6394a90aba4621811ad8-1aba-db70-e063-6394a90a2bf92026-06-03WarningsExact identifier
spl set id: 21811ad8-1aba-db70-e063-6394a90a2bf9

Reported adverse events (FAERS/openFDA)#

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