FDA.reportPublic FDA data

Lubricant PM

Manufacturer
AACE PHARMACEUTICALS, INC.
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:11:57

Label at a glance#

ProductLubricant PM
Active ingredientMINERAL OIL, PETROLATUM
Label structure11 sections

Indications and uses

For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind and sun. May be used as a protectant against further irritation.

Dosage and administration

Pull down the lower lid of the affected eye and apply a small amount (one fourth inch) of ointment to the inside of the eyelid.

Storage and handling

Store away from heat. Protect from freezing. Use only if tape seals on top and bottom flaps are intact. Use before expiration date marked on container. Store at 15° to 30°C (59° to 86°F). RETAIN THIS CARTON FOR FUTURE REFERENCE.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 42.5% and White Petrolatum 57.3%

PURPOSE

OTC - PURPOSE SECTION

Lubricant

USES

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind and sun.
  • May be used as a protectant against further irritation.

WARNINGS

WARNINGS SECTION

  • For external use only.
  • To avoid contamination, do not touch the tip of container to any surface. Replace cap after using.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain.
  • changes in vision occur.
  • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Pull down the lower lid of the affected eye and apply a small amount (one fourth inch) of ointment to the inside of the eyelid.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Store away from heat.
  • Protect from freezing.
  • Use only if tape seals on top and bottom flaps are intact.
  • Use before expiration date marked on container.
  • Store at 15° to 30°C (59° to 86°F).

RETAIN THIS CARTON FOR FUTURE REFERENCE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lanolin Alcohols.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC#: 71406-124-35

Compare to Refresh P.M. ® Ointment active ingredients*

Lubricant PM Ointment

Sensitive

Preservative Free

Ointment for Nighttime Dry Eye Relief

Net Wt. 3.5 g (1/8 oz.) Sterile

Distributed By:

AACE Pharmaceuticals, Inc., Fairfield, NJ 07004

www.aacepharma.com


Rev. 02

*This product is not manufactured by Allergan, Inc. distributor of Refresh PM ® Ointment.

NDC 71406-124-35NDC 71406-124-35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71406-124-35GM - Gram71406-124ce779746-a2e4-408d-a2ab-9780c324225612020-04-20

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
71406-12471406-124-35

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
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML · Source PDF

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
26cedc8e-e891-ff1f-e063-6394a90a3cd4a0bf1958-6e12-66b2-e053-2995a90a3b8c2024-11-13WarningsExact identifier
spl set id: a0bf1958-6e12-66b2-e053-2995a90a3b8c

Reported adverse events (FAERS/openFDA)#

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