FDA.reportPublic FDA data

RoyceDerm Eczema Relief Cream

Manufacturer
RoyceDerm LLC
Effective date
2025-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:04

Label at a glance#

ProductRoyceDerm Eczema Relief Cream
Active ingredientOATMEAL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

OTC - PURPOSE SECTION

Skin Protectant

DOSAGE & ADMINISTRATION SECTION

Temporarily protects and helps relieve minor skin irritationand itching due to Eczema and Rashes

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

do not get into eyes

OTC - ASK DOCTOR SECTION

condition worsens or symptoms last morethan 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Centerright away.(1-800-222-1222)

INDICATIONS & USAGE SECTION

  • Conduct a patch test on a small area of skin to checkfor sensitivity or allergic reaction.
  • Apply as needed to affectedarea.
  • Use 1-2 times daily or as directed by a doctor.
  • For childrenunder 6 months of age: ask a doctor.

OTHER SAFETY INFORMATION

store at room temperature. Avoid excessive heat and direct sunlight.

INACTIVE INGREDIENT SECTION

Aqua, Butylene Glycol, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Camellia Japonica Seed Oil,Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Cetearyl Glucoside, Panthenol, 1,2-Hexanediol, Hydroxyacetophenone, Ceramide 1, Ceramide 3, Ceramide 6 ll, Ectoin,Carboxymethyl Chitosan, Camellia Sinensis Leaf Extract, Tremella Fuciformis Polysaccharide, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Maltodex-trin, Chrysanthellum Indicum Extract, Houttuynia Cordata ExtractOpuntia Streptacantha Stem Extract, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Allantoin, Sodium Hyaluronate, Sodium Polyglutamate, Centella Asiatica Extract, Madecassoside, Asiaticoside

OTC - QUESTIONS SECTION

Email service@roycederm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-010-01RoyceDerm Eczema Relief Cream113 g in 1 CARTONCREAM1131

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
85424-01085424-010-01

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
AQUA059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ASIATICOSIDEPKO39VY215IACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
CHRYSANTHELLUM INDICUM TOPSTJ856D1Z0IACT
ECTOIN7GXZ3858RYIACT
MALTODEXTRIN7CVR7L4A2DIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
PANTHENOLWV9CM0O67ZIACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
OATZ6J799EAJKIACT
OATMEAL8PI54V663YACTIB
N-CARBOXYMETHYLCHITOSAN5R88W82CC6IACT
CERAMIDE 6 IIF1X8L2B00JIACT
PURSLANEM6S840WXG5IACT
PAEONIA SUFFRUTICOSA ROOT7M7E9A2C8JIACT
SODIUM POLYGLUTAMATE (200000 MW)LN8DW52UVLIACT
MADECASSOSIDECQ2F5O6YIYIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
SODIUM HYALURONATEYSE9PPT4THIACT
CETEARYL ALCOHOL2DMT128M1SIACT
SQUALANEGW89575KF9IACT
CAMELLIA JAPONICA SEED OILU37N0S910TIACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL724GKU717MIACT
OPUNTIA STREPTACANTHA STEM3TF9Z1U73OIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CERAMIDE 15THT33P7X7IACT
TREMELLA FUCIFORMIS WHOLE4938BNS0GUIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
ALLANTOIN344S277G0ZIACT
CERAMIDE 34370DF050BIACT

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
RoyceDerm Eczema Relief CreamCOLLOIDAL OATMEAL 1%RoyceDerm LLC3e09f000-01d2-0d21-e063-6294a90ac5482025-09-05WarningsExact identifier
ndc (package): 85424-010-01
ndc (product): 85424-010
ndc11 (package): 85424001001
spl id: 3e09f000-01d3-0d21-e063-6294a90ac548
spl set id: 3e09f000-01d2-0d21-e063-6294a90ac548

Reported adverse events (FAERS/openFDA)#

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