MedPath

Lubricant Drops

Sterile Lubricant Eye Drops

Approved
Approval ID

1ac2fe24-9ff6-48c1-b123-fbc0e48f5304

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 12, 2025

Manufacturers
FDA

CARDINAL HEALTH 110, LLC. DBA LEADER

DUNS: 063997360

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

carboxymethylcellulose sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70000-0090
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
carboxymethylcellulose sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 12, 2025
FDA Product Classification

INGREDIENTS (10)

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDActive
Quantity: 5 mg in 1 mL
Code: K679OBS311
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CHLORITEInactive
Code: G538EBV4VF
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/12/2025

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)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/12/2025

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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/12/2025

Active ingredient

Carboxymethylcellulose sodium 0.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/12/2025

Purpose

Eye lubricant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/12/2025

Warnings

**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

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.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/12/2025

Directions

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/12/2025

Other 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 9/12/2025

Inactive ingredients

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

LOINC: 42229-5Updated: 9/12/2025

.

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

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Lubricant Drops - FDA Drug Approval Details