FDA.reportPublic FDA data

Xerbex Eczema Cream

Manufacturer
Xerbal USA LLC
Effective date
2021-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:24

Label at a glance#

ProductXerbex Eczema Cream
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites

Dosage and administration

Apply as needed

Storage and handling

store at room temperature, 20 to 25 o C(68 to 77 o F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Colloidal Oatmeal 1%   Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

  • rashes
  • eczema
  • poison ivy, oak, or sumac
  • insect bites

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if allergic to any ingredients of this product

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
  • symptoms clear up and occur again within a few days
  • excessive irritation of the skin develops
  • side effects occur. You may report side effects to FDA at 1–800–FDA–1088.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental poisoning .

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature, 20 to 25 oC(68 to 77 oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arlacel 165, Cannabidiol (CBD), Carbomer, Ceteareth-20, Cetyl alcohol, Deionized water, Dimethicone, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Phenyl trimethicone, Stearic acid, Sorbitan stearate, Tromethamine, Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

Pacific Time 8:00am to 5:00pm

1-626-822-8211

PRINCIPAL DISPLAY PANEL - 7.3 oz (206 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC.No : 81021-011-01

Xerbex Eczema Cream

Skin Protectant

Xerbex

Xerbex Eczema CreamXerbex Eczema Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN1
240651colloidal oatmeal 10 MG/ML Topical CreamSCD1
240651Avena sativa 1 % Topical CreamSY1
240651colloidal oatmeal 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81021-011-012023-01-30C16284748780-1f386c649-bab6-0266-e053-dadaa90a7c1aXerbex Eczema Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81021-011-01Xerbex Eczema Cream206 g in 1 TUBECREAM2061
81021-011-01Xerbex Eczema Cream1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81021-011XERBEX ECZEMA CREAM (COLLOIDAL OATMEAL) CREAM [XERBAL USA LLC]1Legacy NDC, 2 package rows20210403_01833c1d-6bf9-4c25-8f6c-3ba132f1e4c6.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
81021-01181021-011-01

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
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
CANNABIDIOL19GBJ60SN5IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
STEARIC ACID4ELV7Z65APIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
TROMETHAMINE023C2WHX2VIACT
XANTHAN GUMTTV12P4NEEIACT
OATMEAL8PI54V663YACTIB

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
bf074850-bc6d-56c1-e053-2995a90ad12f01833c1d-6bf9-4c25-8f6c-3ba132f1e4c62021-04-02WarningsExact identifier
spl id: bf074850-bc6d-56c1-e053-2995a90ad12f
spl set id: 01833c1d-6bf9-4c25-8f6c-3ba132f1e4c6

Reported adverse events (FAERS/openFDA)#

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