FDA.reportPublic FDA data

Equate Restore Tears Drops

Manufacturer
Wal-Mart Stores, Inc. | Altaire Pharmaceuticals, Inc.
Effective date
2018-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:04:54

Label at a glance#

ProductEquate Restore Tears
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM
Label structure10 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. ● May be used as a protectant against further irritation.

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Equate

Restore Tears Drops

49035-189-49

Drug Facts

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.

● May be used as a protectant against further irritation.

Warnings

WARNINGS SECTION

For use in the eyes only.

● Retain outer carton for full product drug facts

Do not use

OTC - DO NOT USE SECTION

● If solution changes color, or becomes cloudy.

When using this product

OTC - WHEN USING SECTION

● avoid contamination, do not touch tip of container

   to any surface.

● replace cap after each 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(s)

● the condition worsens or persists for more than 72 hours.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

● store at room temperature 15º -30ºC (59º-86ºF).

● keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium borate, sodium chloride, water for injection. Vanish® (Stabilized Peroxycomplex System as a preservative). May also contain hydrochloric acid and or sodium hydroxide to adjust pH.

Questions?

OTC - QUESTIONS SECTION

1-888-287-1915

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-189-49
equate
Restore Tears Drops
LUBRICANT EYE DROPS
CARBOXYMETHYCELLULOSE SODIUM 0.5%
Sterile
2 – 0.5 fl oz (15mL) BOTTLES
1 FL OZ (30mL) TOTAL

NDC 49035-189-49 equate Restore Tears Drops LUBRICANT EYE DROPS CARBOXYMETHYCELLULOSE SODIUM 0.5% Sterile 2 – 0.5 fl oz (15mL) BOTTLES 1 FL OZ (30mL) TOTALNDC 49035-189-49 equate Restore Tears Drops LUBRICANT EYE DROPS CARBOXYMETHYCELLULOSE SODIUM 0.5% Sterile 2 – 0.5 fl oz (15mL) BOTTLES 1 FL OZ (30mL) TOTAL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-189-492020-01-31C16284748780-19d75b9d0-3c3d-f424-e053-dadaa90a57ceEquate Restore Tears Drops

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-189EQUATE RESTORE TEARS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [WAL-MART STORES, INC.]1Legacy NDC20180119_c26707f1-2e60-4387-890d-99e2254e7310.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-18949035-189-49

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
CHLORINE DIOXIDE8061YMS4RMIACT
POLIHEXANIDE322U039GMFIACT
HYDROCHLORIC ACIDQTT17582CBCNTM
SODIUM HYDROXIDE55X04QC32ICNTM

Source Document#

Source XML · Source PDF

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
f2eb3005-b0e4-4404-bf97-0a1c9910e5b5c26707f1-2e60-4387-890d-99e2254e73102018-01-19WarningsExact identifier
spl id: f2eb3005-b0e4-4404-bf97-0a1c9910e5b5
spl set id: c26707f1-2e60-4387-890d-99e2254e7310

Reported adverse events (FAERS/openFDA)#

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