FDA.reportPublic FDA data

Lubricant Eye PM

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:50

Label at a glance#

ProductLubricant Eye PM
Active ingredientMINERAL OIL, WHITE PETROLATUM
Label structure12 sections

Storage and handling

Other information store at 15°-25°C (59°-77°F) keep tightly closed see crimp of tube or carton for Lot Number and Expiration Date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Mineral Oil 42.5%

White Petrolatum 57.3%

OTC - PURPOSE SECTION

Purpose

Eye lubricant

INDICATIONS & USAGE SECTION

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.

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or persists for more than 72 hours
  • you experience eye pain, changes in vision, continued redness or irritation of the eye

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • pull down the lower lid of the affected eye
  • apply a small amount (1/4 inch) of the ointment to the inside of the eyelid

STORAGE AND HANDLING SECTION

Other information

  • store at 15°-25°C (59°-77°F)
  • keep tightly closed
  • see crimp of tube or carton for Lot Number and Expiration Date

INACTIVE INGREDIENT SECTION

Inactive ingredient

Lanolin alcohols

OTC - QUESTIONS SECTION

Questions or comments?

call 516-341-0666, 8:30 - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Allergan USA, Inc., owner of the registered trademark Refresh P.M.

Distributed by:

Reliable-1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

SPL UNCLASSIFIED SECTION

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT

SAVE CARTON FOR COMPLETE DRUG FACTS

Lubricant Eye Ointment P.M. provides soothing night time relief for more intense dry, irritated eyes. Ideal for use at bedtime.

Safe to use as often as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Active Ingredients in Refresh P.M.®*

NDC 69618-060-76

Reliable-1® LABORATORIES

LUBRICANT EYE OINTMENT P.M.

Soothes Irritated, Dry Eyes Overnight

PRESERVATIVE FREE

Sterile

Net Wt. 1/8 OZ (3.5 g)

Lubricant Eye Ointment PMLubricant Eye Ointment PM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702008mineral oil 42.5 % / petrolatum 57.3 % Ophthalmic OintmentPSN3
702008mineral oil 0.425 MG/MG / petrolatum 0.573 MG/MG Ophthalmic OintmentSCD3
702008mineral oil 42.5 % / petrolatum, white 57.3 % Ophthalmic OintmentSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-060-76Lubricant Eye PM1 in 1 CARTONOINTMENT13
69618-060-76Lubricant Eye PM3.5 g in 1 TUBEOINTMENT3.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-060LUBRICANT EYE PM (MINERAL OIL, WHITE PETROLATUM) OINTMENT [RELIABLE 1 LABORATORIES LLC]3Current NDC, Legacy NDC, 2 package rows20250212_baec8045-97fe-6f60-e053-2a95a90a050e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-060-76GM - Gram69618-0609b23cf0d-1007-47c0-abda-8bfff66a4eaa12022-09-12

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
69618-06069618-060-76

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
LANOLIN ALCOHOLS884C3FA9HEIACT
MINERAL OILT5L8T28FGPACTIB
WHITE PETROLATUMB6E5W8RQJ4ACTIB

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
Lubricant Eye PMMINERAL OIL, WHITE PETROLATUMReliable 1 Laboratories LLCbaec8045-97fe-6f60-e053-2a95a90a050e2024-12-31WarningsExact identifier
ndc (package): 69618-060-76
ndc (product): 69618-060
ndc11 (package): 69618006076
spl id: 2bc85d47-d669-d2ff-e063-6394a90ab04a
spl set id: baec8045-97fe-6f60-e053-2a95a90a050e

Reported adverse events (FAERS/openFDA)#

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