FDA.reportPublic FDA data

Soothe and Cool Protect

Manufacturer
Medline Industries, Inc. | Dhaliwal Labs Illinois, Llc
Effective date
2019-01-11
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 22:58:11

Label at a glance#

ProductSoothe and Cool Protect
Active ingredientZINC OXIDE, PETROLATUM
Label structure13 sections

Indications and uses

■ Temporarily relieves skin irritation including itching, burning, and discomfort ■ Temporarily forms a protective coating over inflamed tissues to help prevent drying ■ Protects minor skin irritation associated with diaper rash and helps seal out wetness

Dosage and administration

gently cleanse and dry affected area apply liberally to affected area as needed

Storage and handling

Protect from freezing, avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 50%

Zinc Oxide 10%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves skin irritation including itching, burning, and discomfort

■ Temporarily forms a protective coating over inflamed tissues to help prevent drying

■ 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 the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens or does not improve within 7 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

  • gently cleanse and dry affected area
  • apply liberally to affected area as needed

Other information

STORAGE AND HANDLING SECTION

Protect from freezing, avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Benzethonium Chloride, Eugenia Caryophyllus (Clove) Flower Oil, Zea Mays (Corn) Starch, Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Xanthan Gum

SPL UNCLASSIFIED SECTION

www.medline.com

Manufactured in USA for Medline Industries, Inc.,

Mundelein, IL 60060 USA.
1-800-MEDLINE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 53329-004-10

SOOTHE & COOL®

PROTECT

ZINC OXIDE

SKIN PASTE

  • Provides a thick, protective barrier
  • Enhanced with vitamins A & E

Net Wt. 2.5 oz (71 g)

REF MSC095450

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043549Petrolatum 50 % / Zinc Oxide 10 % PastePSN7
1302176Soothe & Cool Skin Paste (white petrolatum 50 % / zinc oxide 10 % ) Topical PastePSN7
1302176petrolatum 0.5 MG/MG / zinc oxide 0.1 MG/MG Paste [Soothe & Cool Skin Paste]SBD7
1043549petrolatum 0.5 MG/MG / zinc oxide 0.1 MG/MG PasteSCD7
1043549Petrolatum 0.5 MG/MG / Zinc Oxide 0.1 MG/MG Topical PasteSY7
1043549Petrolatum 0.5 MG/MG / ZNO 0.1 MG/MG PasteSY7
1302176Petrolatum 0.5 MG/MG / ZNO 0.1 MG/MG Paste [Soothe & Cool Skin Paste]SY7
1043549Petrolatum 50 % / Zinc Oxide 10 % PasteSY7
1302176Soothe & Cool Skin Paste (white petrolatum 50 % / zinc oxide 10 % ) Topical PasteSY7

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
53329-004-022021-01-29C16284748780-1ba0f9c33-389d-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-004-02Soothe and Cool Protect71 g in 1 TUBEPASTE717

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-004SOOTHE AND COOL PROTECT (ZINC OXIDE AND WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES, INC.]7Legacy NDC, 1 package rows20190116_2bd6e71d-5549-7110-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-004-10GM - Gram53329-004ac9f971c-60d6-415b-a2e6-d206a9fa2abe12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-00453329-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
BENZETHONIUM CHLORIDEPH41D05744IACT
CHOLECALCIFEROL1C6V77QF41IACT
CLOVE OIL578389D6D0IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
STARCH, CORNO8232NY3SJIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIB
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
7f3ac9ed-595e-f82e-e053-2a91aa0a86992bd6e71d-5549-7110-e054-00144ff8d46c2019-01-11WarningsExact identifier
spl id: 7f3ac9ed-595e-f82e-e053-2a91aa0a8699
spl set id: 2bd6e71d-5549-7110-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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