FDA.reportPublic FDA data

RoyceDerm Eczema Relief Body Wash-201

Manufacturer
RoyceDerm LLC
Effective date
2026-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-17 21:46:18

Label at a glance#

ProductRoyceDerm Eczema Relief Body Wash
Active ingredientOATMEAL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2%

OTC - PURPOSE SECTION

Skin protectant

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

For external use only

When using this product

Avoid contact with the eye

Stop and ask a doctor

if condition worsens or symptoms last more than 7 days or symptoms clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

  • apply as needed.
  • gently massage onto wet skin.
  • rinse thoroughly and pat dry.

OTHER SAFETY INFORMATION

  • For mild to moderate eczema. Store at room temperature 59°-85°F(15°-30°C).
  • Avoid excessive heat and direct sunlight.

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Laureth Sulfate, AcrylatesCopolymer, Glycerin, Cocamidopropyl Betaine,Sodium Chloride, Lauryl Hydroxysultaine, Sodium Benzoate, Phenoxyethanol, PEG-160 SorbitanTriisostearate, PEG-7 Glyceryl Cocoate, Sodium Hydroxide, Hydroxyethylcellulose, Disodium EDTA.

OTC - QUESTIONS SECTION

Email: service@roycederm.com

Tel:+(307)461-0958

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-02785424-027-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROXYETHYLCELLULOSET4V6TWG28DIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
LUVISET 36005BG6GY6YKIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CALCIUM DISODIUM EDTA8U5D034955IACT
SORBITAN TRIISOSTEARATEP3ZV48C8J1IACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
LAURYL HYDROXYSULTAINE176KKP31OZIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT

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 Body WashCOLLOIDAL OATMEAL 2%RoyceDerm LLC54e74eb4-1b42-a748-e063-6394a90aeb162026-06-23WarningsExact identifier
ndc (package): 85424-027-01
ndc (product): 85424-027
ndc11 (package): 85424002701
spl id: 54e74eb4-1b43-a748-e063-6394a90aeb16
spl set id: 54e74eb4-1b42-a748-e063-6394a90aeb16

Reported adverse events (FAERS/openFDA)#

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