FDA.reportPublic FDA data

ARTIFICIAL TEARS LUBRICANT EYE DROPS

Manufacturer
Ezricare Llc
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:14:54

Label at a glance#

ProductARTIFICIAL TEARS LUBRICANT EYE DROPS
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

• Tamper Evident. Do not use this product if neckband is missing or broken. • RETAIN THIS CARTON FOR FUTURE REFERENCE • Store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose Sodium 10 MG in 1 ml.

Purpose

OTC - PURPOSE SECTION

Eye Lubricant

Uses

INDICATIONS & USAGE SECTION

• for use as a protectant against further irritation or to relieve dryness of the eye

• for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

WARNINGS SECTION

For external use only

• Do not use this product if solution changes color or becomes cloudy

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

When using this product

• to avoid contamination do not touch tip of container to any surface  • replace cap after using. Keep container tightly closed.

• remove contact lens before using

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Questions or comments?

OTC - QUESTIONS SECTION

718-502-6610

between 9 am and 4 pm EST, Monday - Friday.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

• Tamper Evident. Do not use this product if neckband is missing or broken.

• RETAIN THIS CARTON FOR FUTURE REFERENCE

• Store at 15°-30°C (59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Boric Acid

Potassium Chloride

Sodium Chloride

Calcium Chloride Dihydrate.

Magnesium Chloride

Sodium Chlorite

Sodium Hydroxide and 

Water for Injection

SPL UNCLASSIFIED SECTION

Compare to the active Ingredient in Refresh Plus Eye Drops

Refresh, Lubricate and Moisturizes

Distributed by.

EzriCare, LLC

Lakewood, NJ

www.EzriCare.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79503-101-152024-01-11C16284748780-10191ceaa-65ae-198a-e063-dbdaa90aec3eEZRICARE Artificial Tears Lubricant Eye Drops
79503-101-152023-07-28C16284748780-10191ceaa-65ae-198a-e063-dbdaa90aec3eEZRICARE Artificial Tears Lubricant Eye Drops

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79503-101-15ML - Milliliter79503-1012973aa64-370e-41d0-ad26-b5b77bb8c2b412021-04-08

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79503-10179503-101-15

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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311ACTIB
BORIC ACIDR57ZHV85D4IACT
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM CHLORIDE451W47IQ8XIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
SODIUM CHLORITEG538EBV4VFIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

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
35576ab9-9ec7-42bf-83a9-5f5d6d0c5c1cac1ea23c-f1c6-418f-921e-58553ee919cb2024-01-18WarningsExact identifier
spl set id: ac1ea23c-f1c6-418f-921e-58553ee919cb

Reported adverse events (FAERS/openFDA)#

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