Atopis Med

Manufacturer: I Shay Cosmetics Inc
Effective date: 2021-12-03
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:46:08

Label at a glance#

ProductAtopis Med

Active ingredientOATMEAL

Label structure8 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, insect bites

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only

When using this product for the first time

-do an allergy patch test

Stop use and ask a Doctor if

-condition worsens

Keep out of reach of children

Uses

OTC - PURPOSE SECTION

temporarily protects and helps relieve minor skin irritation and itching due to rashes, eczema, insect bites

Indications & Usage Section

Uses temporarily protects and helpsrelieve minor skin irritation and itching due to rashes eczema insect bites

Directions Apply twice daily for best results

OTC Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oats 0.5%

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Apply twice daily for best results.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Myrecil, Olivem 1000, Cetearyl alcohol, Endmusol 20D, Macadamia oil, Safflower oil, Shea butter, glycerin, Harakeke gel, Geogard 221, Hyaluronic acid, Lavender oil, Tocopherol acetate, Manuka oil, Manuka honey, Citric acid, Xantham gum

box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1654149	colloidal oatmeal 0.5 % Topical Cream	PSN	1
1654149	colloidal oatmeal 5 MG/ML Topical Cream	SCD	1
1654149	colloidal oatmeal 0.5 % Topical Cream	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
65112-269-01	2024-01-30	C162847	48780-1	1030e365-0342-111a-e063-dadaa90a10e2	Bionona Atopis Med

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65112-269-01	Atopis Med	75 g in 1 TUBE	CREAM	75		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65112-269	ATOPIS MED (ECZEMA CREAM) CREAM [I SHAY COSMETICS INC]	1	Legacy NDC, 1 package rows	20211231_d2460d8e-1b52-6ffd-e053-2a95a90a468d.zip

Products#

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

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

Atopis Med
Eczema Cream
OATMEAL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65112-269	65112-269-01

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
OATMEAL	8PI54V663Y	ACTIB
WATER	059QF0KO0R	IACT

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
d2460d8e-1b53-6ffd-e053-2a95a90a468d			d2460d8e-1b52-6ffd-e053-2a95a90a468d	2021-12-03	Warnings	Exact identifier spl id: d2460d8e-1b53-6ffd-e053-2a95a90a468d spl set id: d2460d8e-1b52-6ffd-e053-2a95a90a468d

Reported adverse events (FAERS/openFDA)#

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