FDA.reportPublic FDA data

Derma-e Eczema Relief Cream

Manufacturer
Topiderm, Inc | Topiderm, Inc.
Effective date
2020-08-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:53

Label at a glance#

ProductDerma-e Eczema Relief
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to Eczema or Rashes.

Dosage and administration

Apply as needed to entire body, concentrating on areas of dryness.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 or Rashes.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • 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 immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed to entire body, concentrating on areas of dryness.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Arctium Lappa Root Extract, Arctostaphylos Uva-Ursi Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Glucoside, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower, Coco-Caprylate, Coptis Chinensis Root Extract, Dimethicone, Ethylhexylglycerin, Fagara Zanthoxyloides Fruit Extract, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Leuconostoc/Radish Root Ferment Filtrate, Melia Azadirachta Leaf, Phenoxyethanol, Potassium Sorbate, Purifed Water, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tocopheryl Acetate.

SPL UNCLASSIFIED SECTION

Distributed by DERMA E®
Simi Valley, CA 93065, USA

PRINCIPAL DISPLAY PANEL - 113 g Jar Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THERAPEUTIC

100% VEGAN ∙ GMO-FREE
ECO-ETHICAL
CRUELTY-FREE
DOCTOR DEVELOPED

DOCTOR
DEVELOPED

DERMA∙E

Eczema Relief Cream

Neem, Burdock & Bearberry Extracts

For dry skin symptoms associated
with Psoriasis and Eczema

4 OZ / 113 g

Principal Display Panel - 113 g Jar Box
Principal Display Panel - 113 g Jar Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN2
240651colloidal oatmeal 10 MG/ML Topical CreamSCD2
240651Avena sativa 1 % Topical CreamSY2
240651colloidal oatmeal 1 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-870-04Derma-e Eczema Relief1 in 1 BOXCREAM12
51326-870-04Derma-e Eczema Relief113 g in 1 JARCREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-870DERMA-E ECZEMA RELIEF (OATMEAL) CREAM [TOPIDERM, INC]2Current NDC, Legacy NDC, 2 package rows20231219_e1797f81-af4b-49e1-9906-dbfd904a282b.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
51326-87051326-870-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
ALLANTOIN344S277G0ZIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETYL ALCOHOL936JST6JCNIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
COCO-CAPRYLATE4828G836N6IACT
COPTIS CHINENSIS ROOTCXS4LJR7ELIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
JOJOBA OIL724GKU717MIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
ndc (package): 51326-870-04
ndc (product): 51326-870
ndc11 (package): 51326087004
spl id: facf2f71-8433-436b-9d4d-85ef301c7699
spl set id: e1797f81-af4b-49e1-9906-dbfd904a282b

Reported adverse events (FAERS/openFDA)#

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