FDA.reportPublic FDA data

Equate Day and Night Restore Tears

Manufacturer
Wal-Mart Stores, Inc.
Effective date
2018-05-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:55:24

Label at a glance#

ProductEquate Day and Night Restore Tears
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, MINERAL OIL, PETROLATUM
Label structure16 sections

Indications and uses

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

Dosage and administration

pull down lower lid of eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid, every 3-4 hours or as directed by doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Walmart

Equate

Day & Night Restore Tears

15mL & 3.5g

NDC 49035-883-59

Restore PM Lubricant Eye Ointment NDC# 49035-191-50

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 42.5% and White Petrolatum 57.3%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of burning, irritation and discomfort due to dryness of the eye.
  • 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.

When using this product

OTC - WHEN USING SECTION

  • avoid contamination, do not touch tip of container to any surface.
  • replace cap after 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.
  • the condition worsens or persists for more than 72 hours.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. 

Keep this and all drugs 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

  • pull down lower lid of eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid, every 3-4 hours or as directed by doctor.

Other information

OTHER SAFETY INFORMATION

  • Do not use if bottom ridge of tube cap is exposed, and if imprinted seals on side flaps are not intact and completely legible • store at room temperature 15°-30°C (59°-86°F)
  • store away from heat
  • keep from freezing
  • see crimp of tube or box for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

lanolin alcohols

Walmart

Equate

Day & Night Restore Tears

15mL & 3.5g

NDC 49035-883-59

Restore Tears Lubricant Eye Drops NDC 49035-189-13

Drug Facts

Active ingredients

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.
  • 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 this product 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 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.
  • the condition worsens or persists for more than 72 hours.

Keep this and all drugs 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 1 or 2 drops in the affected eye(s) as needed.

Other information

OTHER SAFETY INFORMATION

  • Do not use if imprinted seal on cap is torn, broken or missing
  • store at room temperature 15°-30°C (59°-86°F)
  • keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-883-59
Equate
Day & Night
Restore Tears
15mL & 3.5g

PRINCIPAL DISPLAY PANEL NDC 49035-883-59 Equate Day & Night Restore Tears 15mL & 3.5gPRINCIPAL DISPLAY PANEL NDC 49035-883-59 Equate Day & Night Restore Tears 15mL & 3.5g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-883-592020-01-31C16284748780-19d75b9d0-7d6b-f424-e053-dadaa90a57ceEquate Day and Night Restore Tears

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-883EQUATE DAY AND NIGHT RESTORE TEARS (MINERAL OIL, WHITE PETROLATUM AND CARBOXYMETHYLCELLUOSE SODIUM) KIT [WAL-MART STORES, INC.]3Legacy NDC20180601_b705b4fb-db66-47f4-810c-f3cda4a2d40f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-191-50GM - Gram49035-19181741406-36c2-4190-a092-5b379818f25212018-10-11

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-88349035-883-59
49035-189
49035-191

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM BORATE91MBZ8H3QOIACT
WATER059QF0KO0RIACT
CHLORINE DIOXIDE8061YMS4RMIACT
POLIHEXANIDE322U039GMFIACT
HYDROCHLORIC ACIDQTT17582CBCNTM
SODIUM HYDROXIDE55X04QC32ICNTM
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB
LANOLIN ALCOHOLS884C3FA9HEIACT

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
35879cd7-117e-4942-96f2-19107b4995bdb705b4fb-db66-47f4-810c-f3cda4a2d40f2018-05-07WarningsExact identifier
spl id: 35879cd7-117e-4942-96f2-19107b4995bd
spl set id: b705b4fb-db66-47f4-810c-f3cda4a2d40f

Reported adverse events (FAERS/openFDA)#

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