Major LubriFresh PM

Manufacturer
Major Pharmaceuticals
Effective date
2025-09-05
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:12:41

Label at a glance#

ProductMajor LubriFresh PM
Active ingredientMINERAL OIL, PETROLATUM
Label structure12 sections

Storage and handling

Other information • Store away from heat • Protect from freezing • Use before expiration date marked on container • Store at 59°-86°F (15°-30°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                               Purpose

Mineral oil 15%...................................................Lubricant

White petrolatum 83%.........................................Lubricant

OTC - PURPOSE 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.
  • To avoid contamination, do not touch tip of container to any surface
  • Keep tube tightly closed

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

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

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breast feeding, ask a health professional before use.

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 (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

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

STORAGE AND HANDLING SECTION

Other information

  • Store away from heat
  • Protect from freezing
  • Use before expiration date marked on container
  • Store at 59°-86°F (15°-30°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Lanolin alcohol

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Major Pharmaceuticals

17177 N Laurel Park Dr.,

Suiet 233

Livonia, MI 48150

Rev. 03/24

M-155

Re-order No. 701039

Principal Display Panel - tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-6488-38

LubriFresh™ P.M.

Nighttime Ointment

0.125oz tube label
0.125oz tube label

Principal Display Panel - carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-6488-38

LubiFresh™ P.M.

Nighttime Ointment

Lubricant Eye

Ointment

Relieves irritation and

dryness of the eye

Preservative Free

Sterile

NET WT 0.125 OZ (3.5 g)

0.125oz carton
0.125oz carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6488-38Major LubriFresh PM3.5 g in 1 TUBEOINTMENT3.513
0904-6488-38Major LubriFresh PM1 in 1 CARTONOINTMENT113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6488-38GM - Gram0904-6488ce39ea21-96ea-4be8-bcd1-efba1e59eacf12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HE1

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
0904-64880904-6488-38

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HELOTION / TOPICAL9360 mgExact identifier — unii candidate
4 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HEOINTMENT / TOPICAL452 mgExact identifier — unii candidate
4 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HECREAM / TOPICAL6 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HEOINTMENT / OPHTHALMIC10 %w/wExact identifier — unii candidate
4 equally ranked IID candidates

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
534d168f-68ab-23a6-e063-6394a90a1f51bd85d4b6-7093-4e89-ae7b-2a293a0775f22026-06-02WarningsExact identifier
spl set id: bd85d4b6-7093-4e89-ae7b-2a293a0775f2

Reported adverse events (FAERS/openFDA)#

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