FDA.reportPublic FDA data

Soothe and Cool Protect

Manufacturer
Medline Industries, LP
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:51:21

Label at a glance#

ProductSoothe and Cool Protect
Active ingredientPETROLATUM
Label structure9 sections

Indications and uses

temporarily protects minor cuts scrapes burns temporarily protects and helps relieve chapped or cracked skin and lips helps protect from the drying effects of wind and cold weather

Dosage and administration

apply as needed

Storage and handling

stor at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF) avoid excessive heat and humidity

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 100%

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 and lips
  • helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsenss
  • symptoms last for more than 7 days or clear up and occur again within a few days

When using this produc

OTC - WHEN USING SECTION

  • do not get into eyes

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Other information

STORAGE AND HANDLING SECTION

  • stor at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF)
  • avoid excessive heat and humidity

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

www.medline.com

1-800-MEDLINE

MSC095034

RE19ULI

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-993-042024-10-23C16284748780-11030e365-6750-111a-e063-dadaa90a10e2993 Sooth & Cool Protect white petrolatum
53329-993-042024-07-30C16284748780-11030e365-6750-111a-e063-dadaa90a10e2993 Sooth & Cool Protect white petrolatum
53329-993-042024-01-30C16284748780-11030e365-6750-111a-e063-dadaa90a10e2993 Sooth & Cool Protect white petrolatum

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-993SOOTHE AND COOL PROTECT (PETROLATUM) JELLY [MEDLINE INDUSTRIES, LP]4Legacy NDC20241025_9a008bb9-5630-fdd8-e053-2995a90a9d33.zip

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-99353329-993-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB

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
42db3622-654b-8c17-e063-6294a90a5cf59a008bb9-5630-fdd8-e053-2995a90a9d332025-11-05WarningsExact identifier
spl set id: 9a008bb9-5630-fdd8-e053-2995a90a9d33

Reported adverse events (FAERS/openFDA)#

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