LubriFresh PM
LubriFresh PM (MFR for PLD)
Approved
Approval ID
3b329232-a562-6893-e063-6394a90aa41f
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Jul 31, 2025
Manufacturers
FDA
Hanlim Pharm Co. , LTD
DUNS: 687986034
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Light Mineral Oil, White Petrolatum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11716-7540
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Light Mineral Oil, White Petrolatum
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 31, 2025
FDA Product Classification
INGREDIENTS (3)
LIGHT MINERAL OILActive
Quantity: 150 mg in 1 g
Code: N6K5787QVP
Classification: ACTIB
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
WHITE PETROLATUMActive
Quantity: 830 mg in 1 g
Code: B6E5W8RQJ4
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 7/21/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 7/21/2025
- 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
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 7/21/2025
Light Mineral Oil 15%
White Petrolatum 83%
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 7/21/2025
Eye Lubricant
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 7/21/2025
lanolin alcohols
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 7/21/2025
- 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 7/21/2025
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
LOINC: 34071-1Updated: 7/21/2025
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.