FDA.reportPublic FDA data

Initial Drug Listing - RoyceDerm Seborrheic Dermatitis & Psoriasis Shampoo- 169

Manufacturer
RoyceDerm LLC
Effective date
2026-03-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:40

Label at a glance#

ProductRoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo.
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid USP

OTC - PURPOSE SECTION

Seborrheic dermatitis and psoriasis

DOSAGE & ADMINISTRATION SECTION

Relieves and helps prevent recurrence of scalp: itching, flaking, scaling, redness, and irritation associated with psoriasis and seborrheic dermatitis.

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

condition 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

Stop use and ask a doctor if

condition worsens or does not improve after regular use as directed

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medicaladvice immediately or contact a Poison Control Center right away. (1-800-222-1222)

INDICATIONS & USAGE SECTION

  • Apply shampoo & massage into the scalp.
  • Leave in hair for 3-5 minutes to allow maximum absorption.
  • Rinse and repeat as needed.
  • Use daily for best results.
  • Do not use it on children under 12 years of age unless directed by a doctor.

OTHER SAFETY INFORMATION

Store at room temperature and out of direct sunlight

INACTIVE INGREDIENT SECTION

Water, Disodium EDTA, Citric acid, SodiumCitrate, Plantapon L61l, ChembetaineCAD, Lamesoft PO65, Glycerin, Zemea Propanediol, Chlorhexidine gluconate,Sodium Benzoate, Dex Panthenol,Polyquaternium-44, Calendula extract,Chamomile extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
205023salicylic acid 3 % Medicated ShampooPSN1
205023salicylic acid 30 MG/ML Medicated ShampooSCD1
205023salicylic acid 3 % Medicated ShampooSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrco.de/bfmPmppackage.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-020-01RoyceDerm Seborrheic Dermatitis and Psoriasis Shampoo.250 g in 1 CARTONSHAMPOO2501

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-02085424-020-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
CITRIC ACID2968PHW8QPIACT
GLYCERYL OLEATE4PC054V79PIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
LAURDIMONIUMHYDROXYPROPYL COCOGLUCOSIDES CHLORIDE0O6Q9B860IIACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZACTIB
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CITRATE1Q73Q2JULRIACT
PROPANEDIOL5965N8W85TIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
CALCIUM DISODIUM EDTA8U5D034955IACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM BENZOATEOJ245FE5EUIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYQUATERNIUM-44 (200000 MW)TTD9VOM83OIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT

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 Shampoo.SALICYLIC ACID 3%RoyceDerm LLC4d2f6e29-5d75-6982-e063-6294a90ada8d2026-03-16WarningsExact identifier
ndc (package): 85424-020-01
ndc (product): 85424-020
ndc11 (package): 85424002001
spl id: 4d2f6e29-5d76-6982-e063-6294a90ada8d
spl set id: 4d2f6e29-5d75-6982-e063-6294a90ada8d

Reported adverse events (FAERS/openFDA)#

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