Derma Breeze Skin Protectant Cream

Manufacturer: Greyson International, Inc.
Effective date: 2015-11-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:44:08

Label at a glance#

ProductDerma Breeze Skin Protectant Cream

Active ingredientOATMEAL

Label structure9 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema

Dosage and administration

apply as needed

Contacts and useful links#

PhoneLabel contact1-828-507-7177

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protects and helps relieve minor skin irritation and itching due to:

rashes
eczema

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Medium-Chain Triglycerides, Distearyldimonium Chloride, Saccharide Isomerate, Cetostearyl alcohol, Isocetyl Stearate, Curdlan, Lactic Acid,Glyceryl Monostearate, PPG-51/SMDI Copolymer, Phenoxyethanol, Cetyl Alcohol, Propylene Glycol Stearate, Sodium Chloride, Alpha-Tocopherol Acetate, PEG-10 Soy Sterol

Questions or comments?

OTC - QUESTIONS SECTION

1-828-507-7177

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Derma Breeze

1% colloidal oatmeal

WITH TRILEXON

SKIN PROTECTANT

CREAM

Relieves symptoms of dry skin

Gentle Daily Use Formula

Steroid Free

Fragrance Free

Oil Free Substance

db1

db2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
240651	colloidal oatmeal 1 % Topical Cream	PSN	3
240651	colloidal oatmeal 10 MG/ML Topical Cream	SCD	3
240651	Avena sativa 1 % Topical Cream	SY	3
240651	colloidal oatmeal 1 % Topical Cream	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
OATMEAL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0012345678905	GTIN-13: 0012345678905 EAN-13: 0012345678905 GTIN-12: 012345678905 UPC-A: 012345678905 GTIN storage (14 digits): 00012345678905	DermaBreeze.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69475-5411-0	2020-01-31	C162847	48780-1	9d75b9d1-0378-f424-e053-dadaa90a57ce	Derma Breeze 1% colloidal oatmeal with Trilexon
69475-5411-1	2020-01-31	C162847	48780-1	9d75b9d1-0378-f424-e053-dadaa90a57ce	Derma Breeze 1% colloidal oatmeal with Trilexon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69475-5411-0	Derma Breeze Skin Protectant Cream	28.35 g in 1 TUBE	CREAM	28.35		3
69475-5411-1	Derma Breeze Skin Protectant Cream	1000 g in 1 CONTAINER	CREAM	1000		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69475-5411	DERMA BREEZE SKIN PROTECTANT CREAM (COLLOIDAL OATMEAL) CREAM [GREYSON INTERNATIONAL, INC.]	3	Legacy NDC, 2 package rows	20151120_24736c38-1b5c-6514-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	3
OATMEAL	ACTIVE MOIETY	8PI54V663Y	3
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
CURDLAN	INACTIVE INGREDIENT	6930DL209R	3
DISTEARYLDIMONIUM CHLORIDE	INACTIVE INGREDIENT	OM9573ZX3X	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
ISOCETYL STEARATE	INACTIVE INGREDIENT	3RJ7186O9W	3
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	3
PEG-10 SOY STEROL	INACTIVE INGREDIENT	FG54K98L0Q	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3
PPG-51/SMDI COPOLYMER	INACTIVE INGREDIENT	KQ9JG3O3YA	3
PROPYLENE GLYCOL STEARATE	INACTIVE INGREDIENT	MZM1I680W0	3
SACCHARIDE ISOMERATE	INACTIVE INGREDIENT	W8K377W98I	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Derma Breeze Skin Protectant Cream
Colloidal Oatmeal
DISTEARYLDIMONIUM CHLORIDE
CETYL ALCOHOL
OATMEAL
CURDLAN
MEDIUM-CHAIN TRIGLYCERIDES
CETOSTEARYL ALCOHOL
ISOCETYL STEARATE
SACCHARIDE ISOMERATE
LACTIC ACID
GLYCERYL MONOSTEARATE
PPG-51/SMDI COPOLYMER
WATER
PHENOXYETHANOL
PROPYLENE GLYCOL STEARATE
SODIUM CHLORIDE
ALPHA-TOCOPHEROL ACETATE
PEG-10 SOY STEROL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69475-5411	69475-5411-0, 69475-5411-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DISTEARYLDIMONIUM CHLORIDE	OM9573ZX3X	IACT
CETYL ALCOHOL	936JST6JCN	IACT
OATMEAL	8PI54V663Y	ACTIB
CURDLAN	6930DL209R	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
ISOCETYL STEARATE	3RJ7186O9W	IACT
SACCHARIDE ISOMERATE	W8K377W98I	IACT
LACTIC ACID	33X04XA5AT	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PPG-51/SMDI COPOLYMER	KQ9JG3O3YA	IACT
WATER	059QF0KO0R	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PROPYLENE GLYCOL STEARATE	MZM1I680W0	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
PEG-10 SOY STEROL	FG54K98L0Q	IACT

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 4 · 233 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTIC ACID	LACTIC ACID	33X04XA5AT	LOTION / TOPICAL	5.7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SUSPENSION / ORAL		10170 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL STEARATE	PROPYLENE GLYCOL MONOSTEARATE	MZM1I680W0	LOTION / TOPICAL		60 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	LOTION / TOPICAL	7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	990.3 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATHECAL		9 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / NASAL	330 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUPPOSITORY / RECTAL		140 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii candidate 134 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
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SPRAY / TOPICAL		540 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	GEL / TOPICAL		30 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBMUCOSAL	16 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		11 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	INJECTION / INTRAVENOUS		2232 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER, FOR SUSPENSION / ORAL	3390 mg/5ml		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 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	SUPPOSITORY / RECTAL	35 mg		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
24fc11d4-5d8c-2f53-e054-00144ff8d46c			24736c38-1b5c-6514-e054-00144ff8d46c	2015-11-20	Warnings	Exact identifier spl id: 24fc11d4-5d8c-2f53-e054-00144ff8d46c spl set id: 24736c38-1b5c-6514-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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