FDA.reportPublic FDA data

Leader Lubricant Eye Drops

Manufacturer
Cardinal Health | KC Pharmaceuticals, Inc. | Unimed
Effective date
2023-12-23
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:06:25

Label at a glance#

ProductLeader Lubricant Eye Drops
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM
Label structure9 sections

Indications and uses

for the temoprary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun may be used as a protectant against further irritation

Dosage and administration

to open, twist and pull tab to remove instill 1 or 2 drops in the affected eye(s) as needed and discard container if used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor's instructions

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium 0.5%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for the temoprary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
  • may be used as a protectant against further irritation

Warnings

WARNINGS SECTION

For external use only

Do not use this product if

OTC - DO NOT USE SECTION

  • solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

  • do not reuse
  • once opened, discard
  • to avoid contamination, do not touch tip of container to any surface
  • do not touch unit-dose tip to eye

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 continues
  • redness or irritation of the eye worsens or persists for more than 72 hours

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally swallowed, get medical help or contact a Poison Control Center (1800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • to open, twist and pull tab to remove
  • instill 1 or 2 drops in the affected eye(s) as needed and discard container
  • if used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor's instructions

Other information

OTHER SAFETY INFORMATION

  • store at 15°-25°C (59°-77°F)
  • use only if single-use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride and sodium lactate. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-527-4276

Leader Lubricant Eye Drops Preservative-Free 70 ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Lubricant Eye Drops Preservative-Free 70 ctLeader Lubricant Eye Drops Preservative-Free 70 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN8
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD8
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY8
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY8

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
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
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0012-1Leader Lubricant Eye Drops0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.48
70000-0012-1Leader Lubricant Eye Drops70 in 1 BOXSOLUTION/ DROPS708
70000-0012-2Leader Lubricant Eye Drops30 in 1 BOXSOLUTION/ DROPS308
70000-0012-2Leader Lubricant Eye Drops0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0012LEADER LUBRICANT EYE DROPS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [CARDINAL HEALTH]8Current NDC, Legacy NDC, 4 package rows20240103_8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0012-2EA - Each70000-001252e538a3-b441-4b24-88aa-c50b43160c5e12021-03-02

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-001270000-0012-1, 70000-0012-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CHLORIDEM4I0D6VV5MIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LACTATETU7HW0W0QTIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT

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
Leader Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMCardinal Health8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa2023-12-23WarningsExact identifier
ndc (package): 70000-0012-2
ndc (package): 70000-0012-1
ndc (product): 70000-0012
ndc11 (package): 70000001201
ndc11 (package): 70000001202
spl id: 0d376274-1a7a-5fbc-e063-6394a90a2cf2
spl set id: 8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa

Reported adverse events (FAERS/openFDA)#

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