FDA.reportPublic FDA data

RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream

Manufacturer
RoyceDerm LLC
Effective date
2026-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:49:17

Label at a glance#

ProductRoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 3%

OTC - PURPOSE SECTION

Anti-Seborrheic Dermatitis, Anti-Psoriasis

DOSAGE & ADMINISTRATION SECTION

  • Controls the symptom of seborrheic dermatitis and psoriasis
  • Helps prevent recurrence of sink & scalp itching, irritation, redness, flaking, scaling, associated with psoriasis & seborrheic dermatitis

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

you have a condition that covers a large area of the body.

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse the eyes thoroughly with water.

OTC - STOP USE SECTION

If condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Adults and children 12 years and older: Apply to affected areas one to four times daily or as directed by a doctor.

OTHER SAFETY INFORMATION

Store at room temperature & out of direct sunlight.

INACTIVE INGREDIENT SECTION

Water, Cetyl Alcohol, Propylene Glycol,Niacinamide, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propanediol,C12-20 Alkyl Glucoside, C14-22 Alcohols, Caprylic/CapricTriglyceride, Dimethicone, Helianthus Annuus (Sunflower) SeedOil, Phenoxyethanol, Polyacrylate Crosspolymer-6, Xanthan Gum,Potassium Cetyl Phosphate, Disodium EDTA, Allantoin, Actinidia Chinensis (Kiwi) Fruit Extract, Glycerin, Arctium Lappa (GreaterBurdock) Root Extract, Camellia Sinensis (White Tea) Leaf Extract,Maltodextrin, Glycyrrhiza Glabra (Licorice) Root, Chamomilla Recutita (Matricaria) Flower Extract, Calendula Officinalis(Marigold) Flower Extract, Centella Asiatica (Gotu Kola) Extract,Ethylhexylglycerin, Triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416910salicylic acid 3 % Topical CreamPSN1
416910salicylic acid 30 MG/ML Topical CreamSCD1
416910salicylic acid 3 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-017-01RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream100 g in 1 CARTONCREAM1001

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-01785424-017-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CENTELLA ASIATICA LEAF WATERC4TH45M3K8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
PROPANEDIOL5965N8W85TIACT
C14-22 ALCOHOLSB1K89384RJIACT
POLYACRYLATE CROSSPOLYMER-6Q7UI015FF9IACT
ACTINIDIA CHINENSIS (KIWI) FRUIT JUICE8B5LE1R94SIACT
XANTHAN GUMTTV12P4NEEIACT
TRIETHANOLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ARCTIUM LAPPA SEED OIL5Q5BO6MFW2IACT
CAMELLIA SINENSIS LEAF OILVC855RRT77IACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
SALICYLIC ACIDO414PZ4LPZACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
MALTODEXTRIN7CVR7L4A2DIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
ALLANTOIN344S277G0ZIACT
CALCIUM DISODIUM EDTA8U5D034955IACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT2788Z9758HIACT

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 Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC4ac42528-9210-6936-e063-6294a90a41682026-02-14WarningsExact identifier
ndc (package): 85424-017-01
ndc (product): 85424-017
ndc11 (package): 85424001701
spl id: 4ac42528-9211-6936-e063-6294a90a4168
spl set id: 4ac42528-9210-6936-e063-6294a90a4168

Reported adverse events (FAERS/openFDA)#

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