FDA.reportPublic FDA data

Soothe and Cool

Manufacturer
Medline Industries, LP
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:52:27

Label at a glance#

ProductSoothe and Cool
Active ingredientPETROLATUM
Label structure9 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin or minor skin irritation associated with diaper rash and helps seal out wetness helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips temporarily protects minor cuts, scrapes, and burns

Dosage and administration

apply as needed

Storage and handling

Protect from freezeing. Avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 93.5% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects chafed skin or minor skin irritation associated with diaper rash and helps seal out wetness
  • helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips
  • temporarily protects minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on 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
  • symptoms last for more than 7 days or clear up and occur 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

  • apply as needed

Other information

STORAGE AND HANDLING SECTION

  • Protect from freezeing. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn Oil, Light Mineral Oil, Retinyl Palmitate (Vitamin A Palmitate), Ergocalciferol (Vitamin D)

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for: Medline Industries, Inc.

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE

REF: MSC095094

RD19ULI

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 067label 067

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1367f07-14a3-4895-a6e7-61ee9285308bProduct name120190415

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-067-042024-07-30C16284748780-11030e365-1dcd-111a-e063-dadaa90a10e2067 Soothe and Cool Protect A&D
53329-067-042024-01-30C16284748780-11030e365-1dcd-111a-e063-dadaa90a10e2067 Soothe and Cool Protect A&D

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-067SOOTHE AND COOL (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, LP]6Legacy NDC20221217_405163d3-c61d-4481-999a-b17ec33589d6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-067-04GM - Gram53329-067ec3485a5-715b-4b22-84f8-bd555cc4037412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PetrolatumACTIVE INGREDIENT4T6H12BN9U1
PetrolatumACTIVE MOIETY4T6H12BN9U1
Corn OilINACTIVE INGREDIENT8470G57WFM1
Light Mineral OilINACTIVE INGREDIENTN6K5787QVP1
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVC1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-06753329-067-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ERGOCALCIFEROLVS041H42XCIACT
CORN OIL8470G57WFMIACT
LIGHT MINERAL OILN6K5787QVPIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
PETROLATUM4T6H12BN9UACTIB

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 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Light Mineral OilLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPSUPPOSITORY / VAGINAL1464.9 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPCAPSULE / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPPASTE / DENTAL687 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL376 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPTABLET / ORAL7.5 mgExact identifier — unii candidate
19 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMSUSPENSION / ORAL2.5 ml/5mlExact identifier — unii candidate
11 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMCAPSULE / ORAL918 mgExact identifier — unii candidate
11 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMTABLET / ORAL20 mgExact identifier — unii candidate
11 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPTABLET, COATED / ORAL4.8 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPFILM, EXTENDED RELEASE / TRANSDERMAL4582 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPOIL / AURICULAR (OTIC)419 mgExact identifier — unii candidate
19 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii candidate
19 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
11 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPPASTILLE / ORAL3.6 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPCREAM, AUGMENTED / TOPICAL25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPSYSTEM / TRANSDERMAL170 mgExact identifier — unii candidate
19 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMTABLET, COATED / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii candidate
19 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMSUSPENSION, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii candidate
19 equally ranked IID candidates
Corn OilCORN OIL8470G57WFMTABLET / SUBLINGUAL1.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii candidate
19 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
410cdd0c-4e36-0c69-e063-6294a90aff79405163d3-c61d-4481-999a-b17ec33589d62025-10-13WarningsExact identifier
spl set id: 405163d3-c61d-4481-999a-b17ec33589d6

Reported adverse events (FAERS/openFDA)#

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