FDA.reportPublic FDA data

THREE DOG BEAUTY - NAKERY BEAUTY - ECZEMA RELIEF SOOTHING CREAM (83092-105)

Manufacturer
Three Dog Beauty LLC
Effective date
2022-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:23

Label at a glance#

ProductECZEMA RELIEF SOOTHING 2% COLLOIDAL OATMEAL
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO ECZEMA.

Dosage and administration

APPLY AS NEEDED OR AS DIRECTED BY A DOCTOR.

Storage and handling

STORE AT ROOM TEMPERATURE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

COLLOIDAL OATMEAL 2%

PURPOSE

OTC - PURPOSE SECTION

SKIN PROTECTANT

USES

INDICATIONS & USAGE SECTION

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO ECZEMA.

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES.

STOP USE AND ASK A DOCTOR IF

  • 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 POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY AS NEEDED OR AS DIRECTED BY A DOCTOR.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CETEARYL OLIVATE, SORBITAN OLIVATE, CHENOPODIUM QUINOA SEED OIL, COCOGLYCERIDES, GLYCERIN, CETEARYL ALCOHOL, GLYCERYL LAURATE, GLYCERYL STEARATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HIPPOPHAE RHAMNOIDES (SEABUCKTHORN) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, SQUALANE, GLYCERYL CAPRYLATE, PROPANEDIOL, ALOE BARBADENSIS LEAF EXTRACT, POTASSIUM SORBATE, SALVIA HISPANICA SEED OIL, XANTHAN GUM, HYDROXYETHYLCELLULOSE, CAPRYLHYDROXAMIC ACID, THEOBROMA CACOA (COCOA) SEED BUTTER, TOCOPHEROL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Eczema Cream_6oz01b LBL_Eczema Cream_6oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN1
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD1
1189915colloidal oatmeal 2 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83092-105-062025-01-30C16284748780-12cef2736-8587-d83d-e063-dadaa90ab31fTHREE DOG BEAUTY - NAKERY BEAUTY - ECZEMA RELIEF SOOTHING CREAM (83092-105)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83092-105-06ECZEMA RELIEF SOOTHING2% COLLOIDAL OATMEAL177 mL in 1 TUBECREAM1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83092-105ECZEMA RELIEF SOOTHING 2% COLLOIDAL OATMEAL (COLLOIDAL OATMEAL) CREAM [THREE DOG BEAUTY LLC]1Legacy NDC, 1 package rows20221105_ec9a59c4-5dd5-9879-e053-2a95a90a544a.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83092-10583092-105-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
COCOA BUTTER512OYT1CRRIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SAFFLOWER OIL65UEH262ISIACT
SALVIA HISPANICA SEEDNU0OLX06F8IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SHEA BUTTERK49155WL9YIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
CHENOPODIUM QUINOA SEEDOO4K72NZ2XIACT
COCO-GLYCERIDESISE9I7DNUGIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT
JOJOBA OIL724GKU717MIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
SQUALANEGW89575KF9IACT
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
ec9a6190-9bbe-96b4-e053-2995a90a8179ec9a59c4-5dd5-9879-e053-2a95a90a544a2022-11-03WarningsExact identifier
spl id: ec9a6190-9bbe-96b4-e053-2995a90a8179
spl set id: ec9a59c4-5dd5-9879-e053-2a95a90a544a

Reported adverse events (FAERS/openFDA)#

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