FDA.reportPublic FDA data

Avalon Organics Eczema Therapy Cream

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2021-04-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:39:36

Label at a glance#

ProductAV3630100 Avalon Organics Eczema Relief Body
Active ingredientOATMEAL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Colloidal Oatmeal - 1.5%

DOSAGE & ADMINISTRATION SECTION

Massage cleanser over damp face and body, rinse clean, pat dry. Following immediately with an Eczema Relief cream locks in moisture.

OTC - PURPOSE SECTION

Skin Protectant

WARNINGS SECTION

For external use only. Avoid contacts with eyes. Stop use and ask a doctor if symptoms last more than 7 days or condition worsens.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice(1), Glycerin, Water, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil (1), Glyceryl Stearate SE, Butyrospermum Parkii(Shea Butter(1), Cetearyl Olivate, Shea Butter Ethyl Esters, Sorbitan Olivate, Gluconolactone, , Linum Usatatissimum (Linseed) Seed Oil (1), Archidyl Alcohol, Arginine, Behenyl Alcohol, Calcium Gluconate, Stearyl Alcohol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organic Ingredient

INDICATIONS & USAGE SECTION

Helps protect and relieve skin irritation and itching due to: Eczema, Rashes, Dry skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AV36301 LabelAV36301 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654721colloidal oatmeal 1.5 % Topical CreamPSN6
1654721colloidal oatmeal 15 MG/ML Topical CreamSCD6
1654721colloidal oatmeal 1.5 % Topical CreamSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-1301-82023-01-30C16284748780-1ba0f9c33-29d7-a910-e053-dadaa90a0b85Avalon Organics Eczema Therapy Cream
61995-1301-82021-02-05C16284748780-1ba0f9c33-29d7-a910-e053-dadaa90a0b85Avalon Organics Eczema Therapy Cream
61995-1301-82021-01-29C16284748780-1ba0f9c33-29d7-a910-e053-dadaa90a0b85Avalon Organics Eczema Therapy Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-1301-8AV3630100 Avalon Organics Eczema Relief Body296 g in 1 JARCREAM2966

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-1301AV3630100 AVALON ORGANICS ECZEMA RELIEF BODY (COLLOIDAL OATMEAL) CREAM [THE HAIN CELESTIAL GROUP, INC.]6Legacy NDC, 1 package rows20210413_60b5b3b1-a1a3-e84a-e053-2a91aa0ad4fd.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
61995-130161995-1301-8

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
SAFFLOWER OIL65UEH262ISIACT
SHEA BUTTERK49155WL9YIACT
CETEARYL OLIVATE58B69Q84JOIACT
ARGININE94ZLA3W45FIACT
CALCIUM GLUCONATESQE6VB453KIACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLUCONOLACTONEWQ29KQ9POTIACT
LINSEED OIL84XB4DV00WIACT
STEARYL ALCOHOL2KR89I4H1YIACT
OATMEAL8PI54V663YACTIB
DOCOSANOL9G1OE216XYIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SORBITAN OLIVATEMDL271E3GRIACT

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
bfc790c0-64fd-4ccd-e053-2995a90a2ecc60b5b3b1-a1a3-e84a-e053-2a91aa0ad4fd2021-04-12WarningsExact identifier
spl id: bfc790c0-64fd-4ccd-e053-2995a90a2ecc
spl set id: 60b5b3b1-a1a3-e84a-e053-2a91aa0ad4fd

Reported adverse events (FAERS/openFDA)#

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