FDA.reportPublic FDA data

REFRESH P.M. ® ( Preservative-free) Drug Facts

Manufacturer
Allergan, Inc.
Effective date
2022-06-30
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
monthly-update
Hydrated at
2026-06-03 17:51:37

Label at a glance#

ProductREFRESH P.M.
Active ingredientmineral oil, petrolatum
Label structure10 sections

Indications and 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.

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 42.5%

White Petrolatum 57.3%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Eye lubricant

Uses

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.

Warnings

WARNINGS SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for 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

OTHER SAFETY INFORMATION

  • 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 59°-77°F (15°-25°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lanolin alcohols.

Questions or comments?

OTC - QUESTIONS SECTION

PhonePhone1.800.678.1605

refreshbrand.com

v1.0DFL0667

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-0667-04
PRESERVATIVE-FREE

Refresh
P.M.®

Lubricant Eye Ointment
Nighttime Relief For
Intense Eye Dryness
Net wt. 0.12 oz (3.5 g) Sterile

NDC 0023-0667-04 PRESERVATIVE-FREE Refresh P.M.® Lubricant Eye Ointment Nighttime Relief For Intense Eye Dryness Net wt. 0.12 oz (3.5 g) SterileNDC 0023-0667-04 PRESERVATIVE-FREE Refresh P.M.® Lubricant Eye Ointment Nighttime Relief For Intense Eye Dryness Net wt. 0.12 oz (3.5 g) Sterile

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-0240-04
Refresh
P.M.
Lubricant Eye Ointment
NIGHTTIME OINTMENT
Net wt. 0.12 oz (3.5 g) Sterile

NDC 0023-0240-04 Refresh P.M. Lubricant Eye Ointment NIGHTTIME OINTMENT Net wt. 0.12 oz (3.5 g) SterileNDC 0023-0240-04 Refresh P.M. Lubricant Eye Ointment NIGHTTIME OINTMENT Net wt. 0.12 oz (3.5 g) Sterile

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702008mineral oil 42.5 % / petrolatum 57.3 % Ophthalmic OintmentPSN9
702008mineral oil 0.425 MG/MG / petrolatum 0.573 MG/MG Ophthalmic OintmentSCD9
702008mineral oil 42.5 % / petrolatum, white 57.3 % Ophthalmic OintmentSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-0240-04REFRESH P.M.1 in 1 CARTONOINTMENT19
0023-0240-04REFRESH P.M.3.5 g in 1 TUBEOINTMENT3.59
0023-0240-21REFRESH P.M.1 in 1 CARTONOINTMENT19
0023-0240-21REFRESH P.M.3.5 g in 1 TUBEOINTMENT3.59
0023-0667-04REFRESH P.M.1 in 1 CARTONOINTMENT19
0023-0667-04REFRESH P.M.3.5 g in 1 TUBEOINTMENT3.59
0023-0667-21REFRESH P.M.3.5 g in 1 TUBEOINTMENT3.59
0023-0667-21REFRESH P.M.1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-0240-04GM - Gram0023-0240936d6dc5-9398-41da-86c0-ba83881ea17012012-07-24
0023-0667-04GM - Gram0023-066741a5485b-ec90-4454-b851-436d83e34c4b12022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
mineral oilACTIVE INGREDIENTT5L8T28FGP3
petrolatumACTIVE INGREDIENT4T6H12BN9U3
mineral oilACTIVE MOIETYT5L8T28FGP3
petrolatumACTIVE MOIETY4T6H12BN9U3
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HE3

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
0023-02400023-0240-21, 0023-0240-04
0023-06670023-0667-04, 0023-0667-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
mineral oilT5L8T28FGPACTIB
petrolatum4T6H12BN9UACTIB
lanolin alcohols884C3FA9HEIACT
mineral oilT5L8T28FGPACTIB
petrolatum4T6H12BN9UACTIB
lanolin alcohols884C3FA9HEIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82022-06-30full-release2026-06-01 00:07:37

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 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HEOINTMENT / OPHTHALMIC10 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HEOINTMENT / OPHTHALMIC10 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HEOINTMENT / OPHTHALMIC10 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HEOINTMENT / OPHTHALMIC10 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HEOINTMENT / OPHTHALMIC10 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
lanolin alcoholsLANOLIN ALCOHOLS884C3FA9HEOINTMENT / OPHTHALMIC10 %w/wExact identifier — unii+route+dosage form
6 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
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
ndc (package): 0023-0667-21
ndc (package): 0023-0667-04
ndc (package): 0023-0240-04
ndc (package): 0023-0240-21
ndc (product): 0023-0240
ndc (product): 0023-0667
ndc11 (package): 00023066721
ndc11 (package): 00023024021
ndc11 (package): 00023024004
ndc11 (package): 00023066704
spl id: 9e93a73f-478a-40fe-adca-9b1c30bce567
spl set id: 24365d64-cd94-41cc-a7e1-033102d98114

Reported adverse events (FAERS/openFDA)#

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