FDA.reportPublic FDA data

146 Remedy Essentials Barrier Ointment

Manufacturer
Medline Industries, LP
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:14

Label at a glance#

ProductMedline
Active ingredientWHITE PETROLATUM
Label structure9 sections

Indications and uses

temporarily protects minor cuts, scrapes, and burns helps prevent and temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

for skin protection: apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

White petrolatum 98.3% w/w

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects minor cuts, scrapes, and burns
  • helps prevent and temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve within 7 days, or clears up and occurs again within a few days

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

  • for skin protection: apply as needed

Other information

OTHER SAFETY INFORMATION

  • protect from freezing
  • avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe extract, benzethonium chloride, cholecalciferol (vitamin D), cococaprylate/caprate, corn oil, retinyl palmitate (vitamin A), tocopheryl acetate (vitamin E)

Manufacturing information

SPL UNCLASSIFIED SECTION

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC095380

V3 Rj22UPK

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube V3 RJ22UPKTube V3 RJ22UPK

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-146MEDLINE (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, LP]4Unmatched20241205_0075774d-9b20-7e25-e063-6394a90a0fc1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-14653329-146-14, 53329-146-15, 53329-146-81

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
CHOLECALCIFEROL1C6V77QF41IACT
CORN OIL8470G57WFMIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WHITE PETROLATUMB6E5W8RQJ4ACTIB
BENZETHONIUM CHLORIDEPH41D05744IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT

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
41ed97c9-3376-2dee-e063-6294a90aeaab0075774d-9b20-7e25-e063-6394a90a0fc12025-10-24WarningsExact identifier
spl set id: 0075774d-9b20-7e25-e063-6394a90a0fc1

Reported adverse events (FAERS/openFDA)#

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