FDA.reportPublic FDA data

Update - 85424-015-01

Manufacturer
RoyceDerm LLC
Effective date
2026-08-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-18 02:02:41

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 3%

OTC - PURPOSE SECTION

Psoriasis, Seborrheic Dermatitis,Dandruff Treatment

DOSAGE & ADMINISTRATION SECTION

For the temporary relief of theses ymptoms associated with psoriasis,seborrheic dermatitis - itching - scaling -flaking - redness - irritation of the scalp.Helps prevent recurrence.

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. Ifcontact occurs, rinse the eyes thoroughly with water.

OTC - STOP USE SECTION

condition worsens or does not improve after regular use as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

  • For best results use at least twice a week or as directed by a doctor.
  • Wet hair thoroughly.
  • Massage shampoo into the scalp.
  • Lather, leave on hair & scalp for several minutes.
  • Rinse and repeat.

OTHER SAFETY INFORMATION

  • Store at room temperature
  • Store away from direct sunlight.

INACTIVE INGREDIENT SECTION

Water (Aqua), Artemisia Extract, Polygonum Multiflorum Root Extract, Cnidium Monnieri Fruit Extract, Kochia Scoparia Fruit Extract,Gleditsia Sinensis Extract, Typhonium Giganteum Extract, Stemona Tuberosa Root Extract, Smilax Glabra Root Extract,Borneol, Menthol, Fragrance (Parfum),Cocamide MEA, Citric Acid, Guar Gum,Ethylene Glycol Stearate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130196852495306GTIN-13: 0196852495306
EAN-13: 0196852495306
GTIN-12: 196852495306
UPC-A: 196852495306
GTIN storage (14 digits): 00196852495306		package.jpg
QR code linkQR Codeqrco.de/bfmPmppackage.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-01585424-015-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
COCAMIDE MEAC80684146DIACT
GLYCOL CETEARATEYHX98F77PBIACT
ARTEMISIA AFRA TOPFCU6WET6AAIACT
REYNOUTRIA MULTIFLORA ROOT OIL1HIE915O2JIACT
MENTHOLL7T10EIP3AIACT
SMILAX GLABRA WHOLEH51N91QNEBIACT
BORNEOLM89NIB437XIACT
CNIDIUM MONNIERI FRUIT OILJK0MS9P8YLIACT
PARFUMIDINEA2Q2LHC6MAIACT
STEMONA TUBEROSA ROOT7S9328671ZIACT
WATER059QF0KO0RIACT
SAUROMATUM GIGANTEUM WHOLEC61Y66MY4HIACT
CITRIC ACID2968PHW8QPIACT
GLEDITSIA SINENSIS FRUITA6W0J6UO7QIACT
BASSIA SCOPARIA FRUIT04W97Z676YIACT
GUAR GUME89I1637KEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-30full-release2026-06-01 01:46:35

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 LLC4995ce33-e231-8f86-e063-6394a90af4862026-08-13WarningsExact identifier
ndc (package): 85424-015-01
ndc (product): 85424-015
ndc11 (package): 85424001501
spl id: 58f4f074-08e1-37e6-e063-6294a90a1d5c
spl set id: 4995ce33-e231-8f86-e063-6394a90af486

Reported adverse events (FAERS/openFDA)#

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