FDA.reportPublic FDA data

Equate Restore PM Nighttime Lubricant Eye Ointment

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 01:04:50

Label at a glance#

ProductEquate Restore PM Nighttime Lubricant Eye
Active ingredientMINERAL OIL, PETROLATUM
Label structure10 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 the lower lid of the affected 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

Equate

Restore PM Nighttime Lubricant Eye Ointment

49035-191-50

                       

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 42.5% and White Petrolatum 57.3%

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.  • Save box for complete information.

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.

• condition worsens for 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 immediately (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

• pull down the lower lid of the affected 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

SPL UNCLASSIFIED SECTION

• 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 15º-30ºC (59º-86ºF) • 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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-191-50
equate
Restore PM
NIGHTTIME LUBRICANT
EYE OINTMENT
Sterile
NET WT 0.125 OZ (3.5g)

NDC 49035-191-50 equate Restore PM NIGHTTIME LUBRICANT EYE OINTMENT Sterile NET WT 0.125 OZ (3.5g)NDC 49035-191-50 equate Restore PM NIGHTTIME LUBRICANT EYE OINTMENT Sterile NET WT 0.125 OZ (3.5g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-191-502020-01-31C16284748780-19d75b9d0-3c3a-f424-e053-dadaa90a57ceEquate Restore PM Nighttime Lubricant Eye Ointment

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-191EQUATE RESTORE PM NIGHTTIME LUBRICANT EYE (MINERAL OIL AND PETROLATUM) OINTMENT [WAL-MART STORES, INC.]1Legacy NDC20180119_74e458a3-eb56-42e3-a003-ab52352a1fdd.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 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-19149035-191-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
efe9c35e-163d-490b-98cb-bdf32294a50e74e458a3-eb56-42e3-a003-ab52352a1fdd2018-01-19WarningsExact identifier
spl id: efe9c35e-163d-490b-98cb-bdf32294a50e
spl set id: 74e458a3-eb56-42e3-a003-ab52352a1fdd

Reported adverse events (FAERS/openFDA)#

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