FDA.reportPublic FDA data

Evereden Healing Eczema Treatment

Manufacturer
Eden Brands, Inc.
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:35

Key Label Information#

Active Ingredients And Purpose

ACTIVE INGREDIENT

Colloidal Oatmeal 1%

PURPOSE

Skin Protectant

Uses

USES

Temporarily protects and helps relieve minor skin irritation and itching due to: • eczema • rashes

Warnings

WARNINGS

For external use only. When using this product: Do not get into eyes. Stop use and ask a doctor if: - conditions worsen. - symptoms last more than 7 days or clear up and occur again within a few days.

WARNINGS

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions And Dosage

DIRECTIONS

Apply as needed

Other Label Information

INACTIVE INGREDIENTS

Water(Aqua), Octyldodecanol, Glycerin, Dimethicone, Butyrospermum Parkii (Shea) Butter, Squalane, 1,2-Hexanediol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Cetearyl Olivate, Cetearyl Alcohol, Sorbitan Olivate, Simmondsia Chinensis (Jojoba) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Cocos Nucifera (Coconut) Oil, Spent Grain Wax, Argania Spinosa Kernel Oil, Ceramide AP, Ceramide EOP, Ceramide NP, Sodium PCA, Sodium Hyaluronate, Quercetin, Zinc Oxide, Hydroxyproline, Proline, Panthenol, Sodium Lauroyl Lactylate, Hydroxyacetophenone, Phytosphingosine, Menthyl Ethylamido Oxalate, Cholesterol, Tetrasodium Glutamate Diacetate, Sodium Stearoyl Glutamate, Xanthan Gum, Allantoin, Carbomer, Sodium Hydroxide

Label Images#

Eczema Cream Primary
Eczema Cream Primary
Eczema Cream Secondary
Eczema Cream Secondary

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN3
240651colloidal oatmeal 10 MG/ML Topical CreamSCD3
240651Avena sativa 1 % Topical CreamSY3
240651colloidal oatmeal 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72113-106-032023-03-15C16284748780-1e4f33bdf-a500-d8a0-e053-dadaa90a6e4eEvereden Healing Eczema Treatment
72113-106-032022-07-29C16284748780-1e4f33bdf-a500-d8a0-e053-dadaa90a6e4eEvereden Healing Eczema Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72113-106-03Evereden Healing Eczema Treatment1 in 1 CARTONCREAM13
72113-106-03Evereden Healing Eczema Treatment50 mL in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72113-106EVEREDEN HEALING ECZEMA TREATMENT (COLLOIDAL OATMEAL) CREAM [EDEN BRANDS, INC.]3Current NDC, Legacy NDC, 2 package rows20241215_d43f0eaa-aab0-eaff-e053-2995a90ac5c8.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72113-10672113-106-03

Ingredients#

Name, UNII, Kind table
NameUNIIKind
OCTYLDODECANOL461N1O614YIACT
SQUALANEGW89575KF9IACT
SORBITAN OLIVATEMDL271E3GRIACT
CUCUMIS SATIVUS WHOLE50560UL2YVIACT
ARGANIA SPINOSA SEED8H7X7XB54HIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
COCOS NUCIFERA WHOLE245J88W96LIACT
SIMMONDSIA CHINENSIS SEEDD24K2Q1F6HIACT
CERAMIDE APF1X8L2B00JIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
ARGAN OIL4V59G5UW9XIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
ALLANTOIN344S277G0ZIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETEARYL OLIVATE58B69Q84JOIACT
OATMEAL8PI54V663YACTIB
GLYCERINPDC6A3C0OXIACT
CERAMIDE NP4370DF050BIACT
ZINC OXIDESOI2LOH54ZIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
SODIUM HYDROXIDE55X04QC32IIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CERAMIDE 15THT33P7X7IACT
HYALURONATE SODIUMYSE9PPT4THIACT
QUERCETIN9IKM0I5T1EIACT
HYDROXYPROLINERMB44WO89XIACT
PROLINE9DLQ4CIU6VIACT
PANTHENOLWV9CM0O67ZIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
MENTHYL ETHYLAMIDO OXALATEG2MB8B7PSMIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
XANTHAN GUMTTV12P4NEEIACT

Complete SPL Sections#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to: • eczema • rashes

WARNINGS

WARNINGS SECTION

For external use only. When using this product: Do not get into eyes. Stop use and ask a doctor if: - conditions worsen. - symptoms last more than 7 days or clear up and occur again within a few days.

WARNINGS

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply as needed

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water(Aqua), Octyldodecanol, Glycerin, Dimethicone, Butyrospermum Parkii (Shea) Butter, Squalane, 1,2-Hexanediol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Cetearyl Olivate, Cetearyl Alcohol, Sorbitan Olivate, Simmondsia Chinensis (Jojoba) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Cocos Nucifera (Coconut) Oil, Spent Grain Wax, Argania Spinosa Kernel Oil, Ceramide AP, Ceramide EOP, Ceramide NP, Sodium PCA, Sodium Hyaluronate, Quercetin, Zinc Oxide, Hydroxyproline, Proline, Panthenol, Sodium Lauroyl Lactylate, Hydroxyacetophenone, Phytosphingosine, Menthyl Ethylamido Oxalate, Cholesterol, Tetrasodium Glutamate Diacetate, Sodium Stearoyl Glutamate, Xanthan Gum, Allantoin, Carbomer, Sodium Hydroxide

Source Document#

Source XML