FDA.reportPublic FDA data

Active Ingredient

Manufacturer
SilverCeuticals
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:57:18

Label at a glance#

ProductEczema Therapy
Active ingredientOATMEAL
Label structure13 sections

Indications and uses

Directions: Clean the affected area Apply a small amount of this product on the area once daily May be covered with a sterile bandage If bandaged, let dry first

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
Colloidal Oatmeal 1%Skin Protectant

Purpose

OTC - PURPOSE SECTION

Purpose

Skin Protectant

Uses: Temporarly protects adn helps relieve minor skin irration and itching due to:

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

Do not use

OTC - DO NOT USE SECTION

Stop use and ask a doctor if

  • cconition worsens
  • symptons last more than 7 days or clear up and occur again with a few days

Warnings

OTC - WHEN USING SECTION

Warnings

For external use only

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Instructions for use

INSTRUCTIONS FOR USE SECTION

Directions

  • Apply as needed

Other safety information

Other infromation:

  • For use on mild to maderate exzema or as directed by physician
  • Store at room temperature

Dosage

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium Nitrite

CoCo Betaine

Deionized Water

Citric Acid

Indications and usage

INDICATIONS & USAGE SECTION

Directions:

  • Clean the affected area
  • Apply a small amount of this product on the area once daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first

Warnings

WARNINGS SECTION

Warnings: For external use only

Questions

OTC - QUESTIONS SECTION

Questions? 385-212-4044

SilverCeutial Eczema Therapy and Skin Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 895951NDC 895951

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85951-010-01Eczema Therapy1 g in 1 TUBECREAM13
85951-010-34Eczema Therapy1 g in 1 BOTTLE, DISPENSINGCREAM13

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85951-01085951-010-01, 85951-010-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYLOCEREUS UNDATUS FRUIT JUICE9482Z8LTEMIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
GLYCYRRHIZA GLABRA (LICORICE) RHIZOME/ROOT2788Z9758HIACT
BEHENYL ALCOHOL9G1OE216XYIACT
GLYCERYL 1-STEARATE258491E1RZIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
COLLOIDAL SILVER3M4G523W1GIACT
AVENA SATIVA (OAT) KERNEL OIL3UVP41R77RIACT
MELIA AZADIRACHTA SEED OIL4DKJ9B3K2TIACT
CURCUMA LONGA (TURMERIC) ROOT POWDER856YO1Z64FIACT
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)M4PPW69Y4HIACT
SODIUM HYALURONATEYSE9PPT4THIACT
BETULIN6W70HN7X7OIACT
POLYGLYCERIN-6M51422LRAMIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UIACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF POWDERIJ67X351P9IACT
VACCINIUM MACROCARPON (CRANBERRY) SEED OIL73KDS3BW5EIACT
GINGERC5529G5JPQIACT
DICAPRYLYL ETHER77JZM5516ZIACT
PROPANEDIOL5965N8W85TIACT
SQUALANEGW89575KF9IACT
OLIVE OIL DECYL ESTERS3AQ222F18XIACT
CETYL ALCOHOL936JST6JCNIACT
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
Eczema TherapyCOLLOIDAL OATMEALSilverCeuticals3a26a35e-a098-0e22-e063-6294a90a96b92026-05-13WarningsExact identifier
ndc (package): 85951-010-01
ndc (package): 85951-010-34
ndc (product): 85951-010
ndc11 (package): 85951001001
ndc11 (package): 85951001034
spl id: 51b7a8aa-7632-3da8-e063-6394a90af75b
spl set id: 3a26a35e-a098-0e22-e063-6294a90a96b9

Reported adverse events (FAERS/openFDA)#

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