Mineral Oil with Petroleum

Manufacturer
Rugby Laboratories
Effective date
2025-07-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:07:57

Label at a glance#

ProductMineral Oil with Petroleum
Active ingredientMINERAL OIL, PETROLATUM
Label structure10 sections

Indications and uses

For temporary relief of irritation or dryness in the eye.

Dosage and administration

• Wash your hands. • Pull down lower lid of the affected eye and apply a small amount (1/4” inch) of ointment to the inside of the eyelid, every 3-4 hours or as directed by doctor.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Active ingredientsPurpose
Mineral Oil 3%Lubricant
White Petrolatum 94%Lubricant

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of irritation or dryness in the eye.

Warnings

WARNINGS SECTION

For use in eyes only. Retain outer carton for full product drug facts.

Do not use if: • you are sensitive to any ingredient in this product.

Do not use if bottom ridge of tube is exposed, or if cap of tube is damaged.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if you are experiencing any of the following:

• You experience eye pain or change in vision, continued dryness or irritation of the eye. • The condition worsens. • Symptoms last longer than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Wash your hands. • Pull down lower lid of the affected eye and apply a small amount (1/4” 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. Store at room temperature 15° to 30° C (59° to 86°F) • Keep tube tightly closed. • See crimp of tube or box for lot number and expiration date.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Lanolin alcohol.

OTC - QUESTIONS SECTION

Questions or Comments? • 888-969-6855

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1383-91Mineral Oil with Petroleum3.5 g in 1 TUBEOINTMENT3.53
0536-1383-91Mineral Oil with Petroleum1 in 1 CARTONOINTMENT13

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
0536-13830536-1383-91

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
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB

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
3a384fd2-64c9-ed67-e063-6294a90ac3f0f5b4225e-be2c-9f45-e053-2995a90aa28d2025-07-18WarningsExact identifier
spl id: 3a384fd2-64c9-ed67-e063-6294a90ac3f0
spl set id: f5b4225e-be2c-9f45-e053-2995a90aa28d

Reported adverse events (FAERS/openFDA)#

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