FDA.reportPublic FDA data

Lubricant Drops

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 01:14:23

Label at a glance#

ProductLubricant Drops
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
Label structure11 sections

Indications and uses

▪ For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. ▪ For use as a protectant against further irritation or to relieve dryness of the eye.

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium 0.5%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • For use as a protectant against further irritation or to relieve dryness of the eye.

Warnings

WARNINGS SECTION

  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • If solution changes color or becomes cloudy, do not 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, or if the condition worsens or persists for 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

OTHER SAFETY INFORMATION

  • Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
  • Use before expiration date marked on container.
  • Discard 90 days after opening
  • Store at 59°-86°F (15°-30°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; stabilized oxychloro complex; and sodium chloride. May also 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 Allergan, Inc., owner of the registered trademark

Refresh Tears® Lubricant Eye Drops.

DISTRIBUTED BY CARDINAL HEALT

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Made in India

100% Money Back Guarantee

Return to place of purchase if not satisfied.

Code: MH/DRUGS/28-KD/283

CIN 5698378

REV. 2/21

CIN 5698386

REV. 2/21

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER®

NDC 70000-0090-1

Sterile

Lubricant

Eye Drops

Carboxymethylcellulose

Sodium, 0.5%

Eye Lubricant

Soothing

Relief for Dry Eyes

0.5 FL OZ (15 mL)

0.5% bottle label
0.5% bottle label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER®

NDC 70000-0090-1

Sterile

Lubricant

Eye Drops

Carboxymethylcellulose Sodium, 0.5%

Eye Lubricant

Soothing Relief for Dry Eyes

Actual Bottle Size on Side Panel

COMPARE TO REFRESH TEARS® LUBRICANT EYE DROPS active ingredient*

100% Money Back Guarantee

0.5 FL OZ (15 mL)

0.5% carton (1)
0.5% carton (1)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER®

NDC 70000-0090-2

Sterile

Lubricant

Eye Drops

Carboxymethylcellulose Sodium, 0.5%

Eye Lubricant

Soothing Relief for Dry Eyes

Actual Bottle Size on Side Panel

COMPARE TO REFRESH TEARS® LUBRICANT EYE DROPS active ingredient*

100% Money Back Guarantee

2 BOTTLES, 0.5 FL OZ (15 mL) each

0.5% carton (2)
0.5% carton (2)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN4
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD4
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY4
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0090-12025-09-22C16284748780-11030e365-0f7f-111a-e063-dadaa90a10e2Sterile Lubricant Eye Drops
70000-0090-22025-09-22C16284748780-11030e365-0f7f-111a-e063-dadaa90a10e2Sterile Lubricant Eye Drops
70000-0090-12024-01-30C16284748780-11030e365-0f7f-111a-e063-dadaa90a10e2Sterile Lubricant Eye Drops
70000-0090-22024-01-30C16284748780-11030e365-0f7f-111a-e063-dadaa90a10e2Sterile Lubricant Eye Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0090-1Lubricant Drops1 in 1 CARTONSOLUTION/ DROPS14
70000-0090-1Lubricant Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
70000-0090-2Lubricant Drops2 in 1 CARTONSOLUTION/ DROPS24
70000-0090-2Lubricant Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0090-1ML - Milliliter70000-0090250c11fe-7979-4612-ad80-abe85590f0ce12022-02-07
70000-0090-2ML - Milliliter70000-0090b61129e2-59e8-4a48-9e06-9cef6a3ed84112022-02-07

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
70000-009070000-0090-1, 70000-0090-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311ACTIB
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CHLORITEG538EBV4VFIACT
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
Lubricant DropsCARBOXYMETHYLCELLULOSE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER1ac2fe24-9ff6-48c1-b123-fbc0e48f53042025-09-12WarningsExact identifier
ndc (package): 70000-0090-2
ndc (package): 70000-0090-1
ndc (product): 70000-0090
ndc11 (package): 70000009001
ndc11 (package): 70000009002
spl id: 7032f298-3bfe-4fd2-b240-36ec6015ffbe
spl set id: 1ac2fe24-9ff6-48c1-b123-fbc0e48f5304

Reported adverse events (FAERS/openFDA)#

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