EczaCalm Cream

Manufacturer: I Shay Cosmetics Inc
Effective date: 2024-10-08
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:23:49

Label at a glance#

ProductEczaCalm

Active ingredientOATMEAL

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Organic Colloidal Oatmeal 0.8% ... Skin Protectant

OTC - PURPOSE SECTION

Skin Protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNING: Keep out of reach of children.

INDICATIONS & USAGE SECTION

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

Eczema, rashes, insect bites, poison ivy, oak or sumac

INACTIVE INGREDIENT SECTION

Organic Safflower Oil, Organic Beeswax, Organic Rosehip Seed Oil, Organic Flax Oil, Vitamin E From Sunflowers, Organic Horsetail, Organic Comfrey, Organic Horsetail, Organic Aloe, Organic Calendula, Organic Burdock, Organic Licorice Root, Organic Chamomile, Organic St. John’s Wort, Organic Plantain.

WARNINGS SECTION

For external use only.

Do not use on:
deep puncture wounds
serious burns
animal bites

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

DOSAGE & ADMINISTRATION SECTION

Apply as needed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

drug panel drug panel

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
65112-250-02	2024-10-08	C162847	48780-1	1030e365-0a94-111a-e063-dadaa90a10e2	EczaCalm Cream
65112-250-02	2024-01-30	C162847	48780-1	1030e365-0a94-111a-e063-dadaa90a10e2	EczaCalm Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65112-250-01	EczaCalm	48.2 g in 1 TUBE	OINTMENT	48.2		5
65112-250-02	EczaCalm	1 in 1 BOX	OINTMENT	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65112-250	ECZACALM (SKIN PROTECTANT) OINTMENT [I SHAY COSMETICS INC]	5	Legacy NDC, 2 package rows	20241010_b9e51c5c-e4c9-ed0b-e053-2995a90ad193.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

EczaCalm
Skin Protectant
SAFFLOWER OIL
OATMEAL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65112-250	65112-250-01, 65112-250-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SAFFLOWER OIL	65UEH262IS	IACT
OATMEAL	8PI54V663Y	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2400bf69-a588-5281-e063-6394a90a22cb			b9e51c5c-e4c9-ed0b-e053-2995a90ad193	2024-10-08	Warnings	Exact identifier spl id: 2400bf69-a588-5281-e063-6394a90a22cb spl set id: b9e51c5c-e4c9-ed0b-e053-2995a90ad193

Reported adverse events (FAERS/openFDA)#

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