FDA.reportPublic FDA data

Evereden Intensive Eczema Balm

Manufacturer
Eden Brands Inc.
Effective date
2024-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:37:41

Label at a glance#

ProductEvereden Intensive Eczema Balm
Active ingredientOATMEAL
Label structure12 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Eczema Balm JarEczema Balm Jar

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

USES:

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

  • Eczema
  • Rashes

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:

  • Conditions worsen
  • 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

Directions: Use as needed.

OTHER SAFETY INFORMATION

Other Information: Store product at room temperature

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil, C18-38 Alkyl Hydroxystearoyl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Vegetable Oil, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Butter, Octyldodecanol, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Spent Grain Wax, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Phaeodactylum Tricornutum Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Argania Spinosa Kernel Oil, Hydrogenated Vegetable Oil, Beta-Sitosterol, Boswellia Serrata Gum, Oleic Acid, Linoleic Acid, Phytosterols, Phospholipids, Glyceryl Behenate, Saccharomyces/Zinc Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Iron Ferment, Saccharomyces/Silicon Ferment, Saccharomyces/Copper Ferment, Polyglyceryl-4 Isostearate, Lecithin, Polyglyceryl-3 Diisostearate, Ceramide NG, Ceramide NP, Water (Aqua), Rosmarinus Officinalis (Rosemary) Leaf Extract, Quercetin, Tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eczema Balm CartonEczema Balm Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1486142colloidal oatmeal 2 % Topical OintmentPSN1
1486142colloidal oatmeal 0.02 MG/MG Topical OintmentSCD1
1486142colloidal oatmeal 2 % Topical OintmentSY1
1486142colloidal oatmeal 2 % Topical StickSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72113-109-21Evereden Intensive Eczema Balm45 g in 1 JAROINTMENT451
72113-109-21Evereden Intensive Eczema Balm1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72113-109EVEREDEN INTENSIVE ECZEMA BALM (COLLOIDAL OATMEAL) OINTMENT [EDEN BRANDS INC.]1Current NDC, 2 package rows20241119_2243d4ca-5ca4-54d0-e063-6394a90a3940.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72113-10972113-109-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CANDELILLA WAXWL0328HX19IACT
RIBES NIGRUM SEED OILGKE1188837IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
PHAEODACTYLUM TRICORNUTUMY5W63E7HLVIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
OCTYLDODECANOL461N1O614YIACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
SUNFLOWER OIL UNSAPONIFIABLEST7ZE2WA4MBIACT
OATMEAL8PI54V663YACTIB
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
WATER059QF0KO0RIACT
C18-38 ALKYL HYDROXYSTEAROYL STEARATEWW4FVB2PEMIACT
.BETA.-SITOSTEROLS347WMO6M4IACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
TOCOPHEROLR0ZB2556P8IACT
CERAMIDE NP4370DF050BIACT
ROSEMARYIJ67X351P9IACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
SQUALANEGW89575KF9IACT
CARDIOSPERMUM HALICACABUM LEAF8W2E41J67LIACT
CORN OIL8470G57WFMIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
JOJOBA BUTTERXIA46H803RIACT
SHEA BUTTERK49155WL9YIACT
ARGAN OIL4V59G5UW9XIACT
OLEIC ACID2UMI9U37CPIACT
LINOLEIC ACID9KJL21T0QJIACT
OMEGA-3 FATTY ACIDS71M78END5SIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
CERAMIDE NGC04977SRJ5IACT
QUERCETIN9IKM0I5T1EIACT
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE8N725H4EFNIACT
COCONUT OILQ9L0O73W7LIACT

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
Evereden Intensive Eczema BalmCOLLOIDAL OATMEALEden Brands Inc.2243d4ca-5ca4-54d0-e063-6394a90a39402024-09-16WarningsExact identifier
ndc (package): 72113-109-21
ndc (product): 72113-109
ndc11 (package): 72113010921
spl id: 2243d4ca-5ca5-54d0-e063-6394a90a3940
spl set id: 2243d4ca-5ca4-54d0-e063-6394a90a3940

Reported adverse events (FAERS/openFDA)#

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