FDA.reportPublic FDA data

AV3630200 Avalon Organics Eczema Relief Gentle Cleanser

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2021-02-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:51

Label at a glance#

ProductAV3630200 Avalon Organics Eczema Relief Gentle Cleanser
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

Water, Aloe Barbadensis Leaf Juice(1), Disodium Cocoyl Glutamate, Glyceryl Laurate, Glycerin, Glyceryl Stearate SE, Stearyl Alcohol, Cocos Nucifera (Coconut) Oil (1), Sodium Laurylglucosides Hydroxypropylsulfonate, Xanthan Gum, Linum Usatatissimum (Linseed) Seed Oil (1), Gluconolactone, Calcium Gluconate, Citric Acid, Sodium Chloride, Sodium Benzoate.

(1) Certified Organicf Ingredient

INDICATIONS & USAGE SECTION

Gentle cleanses skin and helps relieve minor skin irritation and iching due to eczema, rashes, dry skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle labelbottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1486782colloidal oatmeal 1.5 % Topical LotionPSN3
1486782colloidal oatmeal 15 MG/ML Topical LotionSCD3
1486782colloidal oatmeal 1.5 % Topical LotionSY3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-1302-82023-01-30C16284748780-1ba0f9c33-478e-a910-e053-dadaa90a0b85AV3630200 Avalon Organics Eczema Relief Gentle Cleanser
61995-1302-82021-02-05C16284748780-1ba0f9c33-478e-a910-e053-dadaa90a0b85AV3630200 Avalon Organics Eczema Relief Gentle Cleanser
61995-1302-82021-01-29C16284748780-1ba0f9c33-478e-a910-e053-dadaa90a0b85AV3630200 Avalon Organics Eczema Relief Gentle Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-1302-8AV3630200 Avalon Organics Eczema Relief Gentle Cleanser325 g in 1 BOTTLE, PLASTICLOTION3253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-1302AV3630200 AVALON ORGANICS ECZEMA RELIEF GENTLE CLEANSER (COLLOIDAL OATMEAL) LOTION [THE HAIN CELESTIAL GROUP, INC.]3Legacy NDC, 1 package rows20210207_60a66a9f-6f72-0b89-e053-2a91aa0a6cce.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-130261995-1302-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM GLUCONATESQE6VB453KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BENZOATEOJ245FE5EUIACT
OATMEAL8PI54V663YACTIB
DISODIUM COCOYL GLUTAMATEMBK0CP8F5AIACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM CHLORIDE451W47IQ8XIACT
LINSEED OIL84XB4DV00WIACT
GLYCERYL LAURATEY98611C087IACT
STEARYL ALCOHOL2KR89I4H1YIACT

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
baa08f4d-158a-67a0-e053-2a95a90a96da60a66a9f-6f72-0b89-e053-2a91aa0a6cce2021-02-05WarningsExact identifier
spl id: baa08f4d-158a-67a0-e053-2a95a90a96da
spl set id: 60a66a9f-6f72-0b89-e053-2a91aa0a6cce

Reported adverse events (FAERS/openFDA)#

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