Skin Protectant

Manufacturer: ELAJ, LLC
Effective date: 2014-07-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:39:56

Label at a glance#

ProductSkin Protectant

Active ingredientOATMEAL

Label structure12 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritations and itching due to eczema

Dosage and administration

Apply as needed or recommended 3-4 x a day initially during flare up and as needed after flareup begins to subside Apply generously before bed to help avoid itching while sleeping

Storage and handling

Store at room temperature

Contacts and useful links#

PhoneLabel contact(949-581-1200

Websitewww.elajnaturally.com

www.elajnaturally.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.0%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritations and itching due to eczema

WARNINGS

WARNINGS SECTION

For external use only

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 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

Apply as needed or recommended 3-4 x a day initially during flare up and as needed after flareup begins to subside
Apply generously before bed to help avoid itching while sleeping

Storage

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

USP White Petrolatum, Lemon Concentrate, Glycerin, Honey, Prunus Amygdalus Dulcis (Almond Oil), Alpha tocopherol (Vitamin E), Beeswax, Soy Wax, Talc, Boric acid, Zinc oxide, Stearic acid, Pistachia lenticus (Mastica), Vanilla

Questions or Comments

OTC - QUESTIONS SECTION

1-844-Buy-ELAJ (949-581-1200) or visit www.elajnaturally.com

Product Packaging Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

57 g, 113 g, and 227 g Box Labels

57 g, 113 g, and 227 g Container Labels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1545142	colloidal oatmeal 1 % Topical Ointment	PSN	1
1545142	colloidal oatmeal 0.01 MG/MG Topical Ointment	SCD	1
1545142	colloidal oatmeal 1 % Topical Ointment	SY	1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69123-111-01	2019-11-27	C162847	48780-1	9855e2a2-3612-60a7-e053-dbdaa90a05bd	SKIN PROTECTANT
69123-111-02	2019-11-27	C162847	48780-1	9855e2a2-3612-60a7-e053-dbdaa90a05bd	SKIN PROTECTANT
69123-111-03	2019-11-27	C162847	48780-1	9855e2a2-3612-60a7-e053-dbdaa90a05bd	SKIN PROTECTANT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69123-111-01	Skin Protectant	1 in 1 BOX	OINTMENT	1	1
69123-111-01	Skin Protectant	57 g in 1 CONTAINER	OINTMENT	57	1
69123-111-02	Skin Protectant	1 in 1 BOX	OINTMENT	1	1
69123-111-02	Skin Protectant	113 g in 1 CONTAINER	OINTMENT	113	1
69123-111-03	Skin Protectant	227 g in 1 CONTAINER	OINTMENT	227	1
69123-111-03	Skin Protectant	1 in 1 BOX	OINTMENT	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69123-111	SKIN PROTECTANT (COLLOIDAL OATMEAL) OINTMENT [ELAJ, LLC]	1	Legacy NDC, 6 package rows	20140812_6537167b-4f8a-485e-bf20-b23d55d5437c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OATMEAL	ACTIVE INGREDIENT	8PI54V663Y	1
OATMEAL	ACTIVE MOIETY	8PI54V663Y	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	1
Vanilla	INACTIVE INGREDIENT	Q74T35078H	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	1

Products#

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

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

Skin Protectant
Colloidal Oatmeal
OATMEAL
PETROLATUM
GLYCERIN
HONEY
ALMOND OIL
.ALPHA.-TOCOPHEROL
YELLOW WAX
Talc
BORIC ACID
ZINC OXIDE
STEARIC ACID
Vanilla

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69123-111	69123-111-01, 69123-111-02, 69123-111-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OATMEAL	8PI54V663Y	ACTIB
PETROLATUM	4T6H12BN9U	IACT
GLYCERIN	PDC6A3C0OX	IACT
HONEY	Y9H1V576FH	IACT
ALMOND OIL	66YXD4DKO9	IACT
.ALPHA.-TOCOPHEROL	H4N855PNZ1	IACT
YELLOW WAX	2ZA36H0S2V	IACT
Talc	7SEV7J4R1U	IACT
BORIC ACID	R57ZHV85D4	IACT
ZINC OXIDE	SOI2LOH54Z	IACT
STEARIC ACID	4ELV7Z65AP	IACT
Vanilla	Q74T35078H	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 · 197 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	GUM, CHEWING / BUCCAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	SUPPOSITORY / RECTAL	375 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
.ALPHA.-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	SOLUTION / ORAL	1.05 mg/1ml		Exact identifier — unii candidate 10 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, COATED PELLETS / ORAL	14 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
ZINC OXIDE	ZINC OXIDE	SOI2LOH54Z	LOTION / TOPICAL	16 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 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
7d1c93bb-808e-4e8d-9670-af940f07a4bc			6537167b-4f8a-485e-bf20-b23d55d5437c	2014-07-25	Warnings	Exact identifier spl id: 7d1c93bb-808e-4e8d-9670-af940f07a4bc spl set id: 6537167b-4f8a-485e-bf20-b23d55d5437c

Reported adverse events (FAERS/openFDA)#

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