Atopis Eczema Therapy Cream

Manufacturer
Bionona Limited | I. Shay Cosmetics, Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:22

Label at a glance#

ProductAtopis Eczema Therapy Cream
Active ingredientOATMEAL
Label structure9 sections

Storage and handling

• Safe for the face and body. • External use only. If irritation should occur discontinue use. • When using this product you may notice a slight tingling sensation; this is normal and will subside. • Do not use if quality seal is broken or missing.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 0.5%

OTC - PURPOSE SECTION

Colloidal Oatmeal 0.5%...... Skin Protectant

INDICATIONS & USAGE SECTION

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

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 right away.

DOSAGE & ADMINISTRATION SECTION

Apply twice daily for best results.

STORAGE AND HANDLING SECTION

• Safe for the face and body.
• External use only. If irritation should occur discontinue use.
• When using this product you may notice a slight tingling sensation; this is normal and will subside.
• Do not use if quality seal is broken or missing.

INACTIVE INGREDIENT SECTION

Myriphytase extract (Cocos nucifera (coconut) water, Bee pollen, Cocos nucifera coconut) oil, Notofagus fuca honeydew), Cetearyl olivate, Sorbitan olivate, Carthamus tinctorius (Safflower) seed oil, Cetearyl alcohol, Glycerin, Macadamia ternifolia seed oil, Butyrospermum parkii (shea butter), Tocopheryl acetate, Sodium stearoyl glutamate, benzyl alcohol, dehydracetic acid, Citrus aurantium bergamia (bergamot) fruit oil, Xanthan gum, Citric acid.

OTC - QUESTIONS SECTION

(855) 969-5002 or contact@atopis.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ATOPIS

Eczema
Therapy Cream

Skin Protectant


Cream for eczema, rash and insect bite relief

Clinically shown to relieve and protect dry, itchy, irritated skin, due to eczema


• Soothes, nourishes and restores moisture
• No parabens, no solvents, no artificial fragrances
• Clinically trialed on humans, not tested on animals

Product of New Zealand
E Net Wt 2.6 oz/75g

AtopisAtopis

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654149colloidal oatmeal 0.5 % Topical CreamPSN2
1654149colloidal oatmeal 5 MG/ML Topical CreamSCD2
1654149colloidal oatmeal 0.5 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71570-001-012024-01-30C16284748780-11030e365-57c5-111a-e063-dadaa90a10e28d4b4a14-b631-f2fa-e053-2a95a90a932f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71570-001-01Atopis Eczema Therapy Cream75 g in 1 BOTTLECREAM752
71570-001-01Atopis Eczema Therapy Cream1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71570-001ATOPIS ECZEMA THERAPY CREAM (COLLOIDAL OATMEAL) CREAM [BIONONA LIMITED]2Current NDC, Legacy NDC, 2 package rows20241215_8d4b4a14-b631-f2fa-e053-2a95a90a932f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71570-00171570-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atopis Eczema Therapy CreamCOLLOIDAL OATMEALBionona Limited8d4b4a14-b631-f2fa-e053-2a95a90a932f2024-12-12WarningsExact identifier
ndc (package): 71570-001-01
ndc (product): 71570-001
ndc11 (package): 71570000101
spl id: 2919c17e-5f02-d32a-e063-6294a90abacb
spl set id: 8d4b4a14-b631-f2fa-e053-2a95a90a932f

Reported adverse events (FAERS/openFDA)#

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