LEADER LUBRICANT EYE DROPS

Manufacturer
HANLIM PHARM. CO., LTD.
Effective date
2010-04-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:24:29

Label at a glance#

ProductLEADER LUBRICANT EYE DROPS
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients-------------------------------------------------Purpose

Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant

Propylene Glycol (0.3%)---------------------------------------Lubricant

OTC - PURPOSE SECTION

Uses

For the temporary relief of burning and irritation due to eye dryness.

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after each use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you experience 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 immediately.

INDICATIONS & USAGE SECTION

Directions

  • Put 1 or 2 drops in the affected eye/s as needed.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,

Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Zinc Chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelimage of carton labelEnter section text here

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN5
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD5
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11716-1192-62020-01-31C16284748780-19d75b9d0-a5d0-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11716-1192-6LEADER LUBRICANT EYE DROPS1 in 1 CARTONSOLUTION15
11716-1192-6LEADER LUBRICANT EYE DROPS15 mL in 1 BOTTLESOLUTION155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11716-1192LEADER LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400) SOLUTION [HANLIM PHARM. CO., LTD.]5Legacy NDC, 2 package rows20100511_dcec9de2-d680-4829-9557-7ace9f506a3b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQ5
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V35
POLYETHYLENE GLYCOLACTIVE MOIETY3WJQ0SDW1A5
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V35
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D45
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5M5
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8E5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB5
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O5
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I105
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X5
WATERINACTIVE INGREDIENT059QF0KO0R5
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16B5

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
11716-119211716-1192-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 345 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBPOWDER / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5 mgExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBCAPSULE, LIQUID FILLED / ORALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii candidate
134 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION, SOLUTION / INTRA-ARTERIAL11 mgExact identifier — unii candidate
16 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BSOLUTION/ DROPS / OPHTHALMICNAExact identifier — unii candidate
5 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / OPHTHALMIC13 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XENEMA / RECTAL0.7 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBCREAM / TOPICAL38 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XIMPLANT / SUBCUTANEOUS77 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / URETERALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / ORALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVENOUS28773 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INFILTRATION0.37 %w/vExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVITREAL10 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSOLUTION / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OINJECTION, SUSPENSION / INTRAVITREAL0.03 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RESPIRATORY (INHALATION)108 mgExact identifier — unii candidate
134 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10TABLET / ORAL231 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAOCULAR320 mgExact identifier — unii candidate
134 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION / AURICULAR (OTIC)0.6 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SUSPENSION / ORALNAExact identifier — unii candidate
18 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / URETHRALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.18 %w/vExact identifier — unii candidate
148 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTABLE, LIPOSOMAL / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSUSPENSION / AURICULAR (OTIC)0.06 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BSOLUTION / OPHTHALMICNAExact identifier — unii candidate
5 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRATUMORADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRAVENOUS720 mgExact identifier — unii candidate
148 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4EMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / TOPICAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOAP / TOPICAL1.26 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / EPIDURALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10CAPSULE / ORAL62 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / INTRAMUSCULAR9 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / PARENTERAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBPOWDER, FOR SUSPENSION / ORAL125 mgExact identifier — unii candidate
148 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10POWDER / NASALNAExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / PERIDURALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates

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
8a2dd2b4-e592-41a3-995f-c70427015383dcec9de2-d680-4829-9557-7ace9f506a3b2010-04-28WarningsExact identifier
spl id: 8a2dd2b4-e592-41a3-995f-c70427015383
spl set id: dcec9de2-d680-4829-9557-7ace9f506a3b

Reported adverse events (FAERS/openFDA)#

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