FDA.reportPublic FDA data

LubriFresh PM

Manufacturer
Hanlim Pharm Co. , LTD
Effective date
2025-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:55

Label at a glance#

ProductLubriFresh PM
Active ingredientLIGHT MINERAL OIL, WHITE PETROLATUM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Light Mineral Oil 15%

White Petrolatum 83%

OTC - PURPOSE SECTION

Eye Lubricant

INDICATIONS & USAGE SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

lanolin alcohols

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.

WARNINGS SECTION

For external use only

When using this product

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

Stop use and ask a doctor if

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

Keep out of reach of children.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LubriFresh PMLubriFresh PM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086613LubriFresh P.M. 15 % / 83 % Ophthalmic OintmentPSN1
746083mineral oil 15 % / petrolatum 83 % Ophthalmic OintmentPSN1
1086613mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic Ointment [Lubrifresh P.M.]SBD1
746083mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic OintmentSCD1
1086613Lubrifresh PM (mineral oil 15 % / white petrolatum 83 % ) Ophthalmic OintmentSY1
746083mineral oil 15 % / petrolatum, white 83 % Ophthalmic OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11716-7540-1LubriFresh PM1 in 1 BOXOINTMENT11
11716-7540-1LubriFresh PM3.5 g in 1 TUBEOINTMENT3.51

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
11716-754011716-7540-1

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
LIGHT MINERAL OILN6K5787QVPACTIB
LANOLIN ALCOHOLS884C3FA9HEIACT
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
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMHanlim Pharm Co. , LTD3b329232-a562-6893-e063-6394a90aa41f2025-07-31WarningsExact identifier
ndc (package): 11716-7540-1
ndc (product): 11716-7540
ndc11 (package): 11716754001
spl id: 3b32b603-a3ca-586c-e063-6294a90aedd1
spl set id: 3b329232-a562-6893-e063-6394a90aa41f

Reported adverse events (FAERS/openFDA)#

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