FDA.reportPublic FDA data

071 Soothe & Cool Moisture Barrier Ointment

Manufacturer
Medline Industries, LP
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:39:16

Label at a glance#

ProductSoothe and Cool Moisture Barrier
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

temporarily protects minor: cuts, scrapes, burns temporarily protects and helps relieve chapped or cracked skin helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness

Dosage and administration

for skin protection: apply as needed for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 98.3%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects minor: cuts, scrapes, burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness

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
  • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

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

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC095380

V1 RK21UPK

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label V1 RK21UPKLabel V1 RK21UPK

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-071-142023-08-08C16284748780-10191ceaa-6aa8-198a-e063-dbdaa90aec3e071 Soothe & Cool Moisture Barrier Ointment
53329-071-152023-08-08C16284748780-10191ceaa-6aa8-198a-e063-dbdaa90aec3e071 Soothe & Cool Moisture Barrier Ointment
53329-071-162023-08-08C16284748780-10191ceaa-6aa8-198a-e063-dbdaa90aec3e071 Soothe & Cool Moisture Barrier Ointment
53329-071-962023-08-08C16284748780-10191ceaa-6aa8-198a-e063-dbdaa90aec3e071 Soothe & Cool Moisture Barrier Ointment
53329-071-142023-07-28C16284748780-10191ceaa-6aa8-198a-e063-dbdaa90aec3e071 Soothe & Cool Moisture Barrier Ointment
53329-071-152023-07-28C16284748780-10191ceaa-6aa8-198a-e063-dbdaa90aec3e071 Soothe & Cool Moisture Barrier Ointment
53329-071-162023-07-28C16284748780-10191ceaa-6aa8-198a-e063-dbdaa90aec3e071 Soothe & Cool Moisture Barrier Ointment
53329-071-962023-07-28C16284748780-10191ceaa-6aa8-198a-e063-dbdaa90aec3e071 Soothe & Cool Moisture Barrier Ointment

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-071SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, LP]9Legacy NDC20241127_59625382-2769-4c91-9c53-e19dfd6ca115.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-071-15GM - Gram53329-071ad0179fe-7181-45ac-92fb-67246b68165c12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4N1
ALOEINACTIVE INGREDIENTV5VD430YW91
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D057441
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF411
CORN OILINACTIVE INGREDIENT8470G57WFM1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1

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
53329-07153329-071-14, 53329-071-15, 53329-071-16, 53329-071-96

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
CHOLECALCIFEROL1C6V77QF41IACT
BENZETHONIUM CHLORIDEPH41D05744IACT
CORN OIL8470G57WFMIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
PETROLATUM4T6H12BN9UACTIB
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ALOEV5VD430YW9IACT

Source Document#

Source XML

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 · 17 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744CREAM / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / SUBLINGUAL1.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / ORAL20 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION/ DROPS / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAVENOUS1 mgExact identifier — unii candidate
6 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCAPSULE / ORAL918 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
6 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION / ORAL2.5 ml/5mlExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, COATED / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744SOLUTION / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
BENZETHONIUM CHLORIDEBENZETHONIUM CHLORIDEPH41D05744INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.5 mgExact identifier — unii candidate
6 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 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
40d431a1-eaeb-ffd7-e063-6294a90aa55959625382-2769-4c91-9c53-e19dfd6ca1152025-10-10WarningsExact identifier
spl set id: 59625382-2769-4c91-9c53-e19dfd6ca115

Reported adverse events (FAERS/openFDA)#

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