FDA.reportPublic FDA data

Soothe and Cool Inzo

Manufacturer
Medline Industries, LP
Effective date
2021-10-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:30:44

Label at a glance#

ProductSoothe and Cool Inzo
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

■ Helps treat and prevent diaper rash caused from wetness, urine and/or stool ■ Temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

■ Helps treat and prevent diaper rash caused from wetness, urine and/or stool

■ 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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzethonium Chloride, Cetyl Alcohol, Ergocalciferol, Glycerol Monostearate, Lanolin, PCMX Surcide, Quaternium-15, Sodium Lauryl Sulfate, Sorbitol, Vitamin A Palmitiate, Vitamin E Acetate, Water, Zinc Oxide

SPL UNCLASSIFIED SECTION

REF MSC095422

www.medline.com
Manufactured in USA with
domestic and imported materials
for Medline Industries, Inc.,
Mundelein, IL 60060 USA.
1-800-MEDLINE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOOTHE & COOL®

Protect

INZO® BARRIER CREAM

  • Invisible Skin Protectant
  • 5% Dimethicone
  • Zinc Oxide

.24 FL OZ (7 mL)

labellabel

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-77653329-776-96, 53329-776-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744IACT
CETYL ALCOHOL936JST6JCNIACT
ERGOCALCIFEROLVS041H42XCIACT
ZINC OXIDESOI2LOH54ZIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LANOLIN7EV65EAW6HIACT
CHLOROXYLENOL0F32U78V2QIACT
QUATERNIUM-15E40U03LEM0IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OACTIB

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
cf2ebdbb-6134-6fcc-e053-2a95a90a194d2bd1149a-5687-6e11-e054-00144ff8d46c2021-10-25WarningsExact identifier
spl id: cf2ebdbb-6134-6fcc-e053-2a95a90a194d
spl set id: 2bd1149a-5687-6e11-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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