FDA.reportPublic FDA data

AV3630000 Avalon Organics Eczema Relief Intensive

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#

ProductAV3630000 Avalon Organics Eczema Relief Intensive
Active ingredientOATMEAL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Colloidal Oatmeal - 1.5%

DOSAGE & ADMINISTRATION SECTION

Instantly sootheand protect skin by smoothing over areas of intense irritation.

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)

Carthamus Tinctorius (Safflower) Seed Oil (1)

Cocos Nucifera (Coconut) Oil (1)

Glycerin

Cetearyl Olivate

Shea Butter Ethyl Esters

Sorbitan Olivate

Glyceryl Stearate SE

Aqua (Purified Water)

Butyrospermum Parkii (Shea) Butter (1)

Linum Usitatissimum (Linseed) Seed Oil (1)

C10-18 Triglycerides

Gluconolactone

Behenyl Alcohol

Archidyl Alcohol

Arginine

Biosaccharide gum-1

Calcium Gluconate

Glyceryl Caprylate

Sodium Anisate

Sodium Levulinate

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

AV36300 LabelAV36300 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
61995-1300-32023-01-30C16284748780-1ba0f9c33-1f40-a910-e053-dadaa90a0b85AV3630000 Avalon Organics Eczema Relief Intensive
61995-1300-32021-02-05C16284748780-1ba0f9c33-1f40-a910-e053-dadaa90a0b85AV3630000 Avalon Organics Eczema Relief Intensive
61995-1300-32021-01-29C16284748780-1ba0f9c33-1f40-a910-e053-dadaa90a0b85AV3630000 Avalon Organics Eczema Relief Intensive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-1300-3AV3630000 Avalon Organics Eczema Relief Intensive89 g in 1 TUBECREAM896

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-1300AV3630000 AVALON ORGANICS ECZEMA RELIEF INTENSIVE (COLLOIDAL OATMEAL) CREAM [THE HAIN CELESTIAL GROUP, INC.]6Legacy NDC, 1 package rows20210413_60b6eaa6-afab-24a7-e053-2991aa0a3862.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-130061995-1300-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
DOCOSANOL9G1OE216XYIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SORBITAN OLIVATEMDL271E3GRIACT
OATMEAL8PI54V663YACTIB
SODIUM LEVULINATEVK44E1MQU8IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
SODIUM ANISATEF9WFJ28MV9IACT
SHEA BUTTER ETHYL ESTERSV2CI786FPGIACT

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
bfc79738-95c4-b1c2-e053-2a95a90ad7d960b6eaa6-afab-24a7-e053-2991aa0a38622021-04-12WarningsExact identifier
spl id: bfc79738-95c4-b1c2-e053-2a95a90ad7d9
spl set id: 60b6eaa6-afab-24a7-e053-2991aa0a3862

Reported adverse events (FAERS/openFDA)#

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