Soothe and Cool INZO Barrier

Manufacturer: Medline Industries, LP
Effective date: 2021-11-17
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-05-31 23:44:56

Label at a glance#

ProductSoothe and Cool INZO Barrier

Active ingredientDIMETHICONE

Label structure7 sections

Indications and uses

Temporarily protects and helps relieve chapped or cracked skin minor cuts, scrapes, and burns

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

Temporarily protects

and helps relieve chapped or cracked skin
minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

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
symptoms last 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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzethonium Chloride, Cetyl Alcohol, Chloroxylenol, Cholecalciferol, Glyceryl Stearate, Lanolin, Quaternium-15, Retinyl Palmitate, Sodium Cocoyl Isethionate, Sorbitol, Tocopheryl Acetate, Water, Zinc Oxide.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Soothe&Cool INZO Barrier Cream

NDC: 53329-777-04

Soothe & Cool

Protect

INZO Barrier Cream

with 5% dimethicone

Invisible Skin Protectant

Contains Zinc Oxide

Extra-Strength

REF MSC095420

Medline

4 Fl. Oz. (118.29 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
259090	dimethicone 5 % Topical Cream	PSN	10
259090	dimethicone 50 MG/ML Topical Cream	SCD	10
259090	dimethicone 5 % Topical Cream	SY	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53329-777-04	2023-01-30	C162847	48780-1	f386c649-c7b6-0266-e053-dadaa90a7c1a	777 Soothe and Cool INZO Barrier
53329-777-96	2023-01-30	C162847	48780-1	f386c649-c7b6-0266-e053-dadaa90a7c1a	777 Soothe and Cool INZO Barrier

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-777-04	Soothe and Cool INZO Barrier	118 mL in 1 TUBE	CREAM	118	10
53329-777-96	Soothe and Cool INZO Barrier	144 in 1 BOX	CREAM	144	10
53329-777-96	Soothe and Cool INZO Barrier	8 mL in 1 PACKET	CREAM	8	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-777	SOOTHE AND COOL INZO BARRIER (DIMETHICONE) CREAM [MEDLINE INDUSTRIES, LP]	10	Legacy NDC, 3 package rows	20211118_9e6bfd97-dcbe-4f3d-8a2e-b2b7af66fae3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-777-04	ML - Milliliter	53329-777	63887ede-98ca-40ce-b10b-3c12a2c20838	1	2015-04-03
53329-777-96	ML - Milliliter	53329-777	ec789d1f-20a0-416f-8abc-4083967742b0	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	4
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	4
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	4
BENZETHONIUM CHLORIDE	INACTIVE INGREDIENT	PH41D05744	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	4
CHLOROXYLENOL	INACTIVE INGREDIENT	0F32U78V2Q	4
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	4
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	4
QUATERNIUM-15	INACTIVE INGREDIENT	E40U03LEM0	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	4
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	4

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Soothe and Cool INZO Barrier
Dimethicone
BENZETHONIUM CHLORIDE
CETYL ALCOHOL
CHLOROXYLENOL
CHOLECALCIFEROL
GLYCERYL MONOSTEARATE
LANOLIN
QUATERNIUM-15
VITAMIN A PALMITATE
SORBITOL
.ALPHA.-TOCOPHEROL ACETATE, D-
WATER
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-777	53329-777-04, 53329-777-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZETHONIUM CHLORIDE	PH41D05744	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CHLOROXYLENOL	0F32U78V2Q	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
LANOLIN	7EV65EAW6H	IACT
QUATERNIUM-15	E40U03LEM0	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
SORBITOL	506T60A25R	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
WATER	059QF0KO0R	IACT
ZINC OXIDE	SOI2LOH54Z	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

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 2 · 111 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
CHLOROXYLENOL	CHLOROXYLENOL	0F32U78V2Q	CREAM / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
BENZETHONIUM CHLORIDE	BENZETHONIUM CHLORIDE	PH41D05744	SOLUTION/ DROPS / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SUPPOSITORY / RECTAL	375 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
QUATERNIUM-15	QUATERNIUM-15	E40U03LEM0	CREAM, AUGMENTED / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SOLUTION / RESPIRATORY (INHALATION)	3.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / RECTAL		17 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
QUATERNIUM-15	QUATERNIUM-15	E40U03LEM0	LOTION / TOPICAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
BENZETHONIUM CHLORIDE	BENZETHONIUM CHLORIDE	PH41D05744	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
BENZETHONIUM CHLORIDE	BENZETHONIUM CHLORIDE	PH41D05744	SOLUTION / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENZETHONIUM CHLORIDE	BENZETHONIUM CHLORIDE	PH41D05744	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d103ac3e-c8da-4546-e053-2995a90aa0f5			9e6bfd97-dcbe-4f3d-8a2e-b2b7af66fae3	2021-11-17	Warnings	Exact identifier spl id: d103ac3e-c8da-4546-e053-2995a90aa0f5 spl set id: 9e6bfd97-dcbe-4f3d-8a2e-b2b7af66fae3

Reported adverse events (FAERS/openFDA)#

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