FDA.reportPublic FDA data

RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar

Manufacturer
RoyceDerm LLC
Effective date
2025-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:12:03

Label at a glance#

ProductRoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 2%

OTC - PURPOSE SECTION

  • Anti-dandruff
  • Anti-seborrheic dermatitis

DOSAGE & ADMINISTRATION SECTION

Controls and reduces the symptoms of dandruff and seborrheic dermatitis

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

you have a conditionthat covers a large area of the body.

OTC - WHEN USING SECTION

avoid contact with eyesIf contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

if condition worsensor does not improve.

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthprofessional before use.

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

  • Cleanse and dry skin.
  • Apply a thin layer to affected areas.
  • Use thricedaily or as directed by a doctor.

OTHER SAFETY INFORMATION

store at room temperature.

INACTIVE INGREDIENT SECTION

Tetrasodium EDTA, Sodium Cocoyl Isethionate, Glycerin, Polyquaternium-7, Menthol, Adep Bovis, Olea Europaea(Olive) fruit Oil, Butyrospermum Parkii (Shea Butter)

OTC - QUESTIONS SECTION

Email service@roycederm.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pyrithione ZincPyrithione Zinc

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283707zinc pyrithione 2 % Medicated Bar SoapPSN1
283707zinc pyrithione 0.02 MG/MG Medicated Bar SoapSCD1
283707zinc pyrithione 2 % Medicated Bar SoapSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-008-01RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar226 g in 1 CARTONSOAP2261

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85424-00885424-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
POLYQUATERNIUM-70L414VCS5YIACT
MENTHOLL7T10EIP3AIACT
TETRASODIUM EDTAMP1J8420LUIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
ADEPS BOVIS98HPY76U4WIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT

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 Dandruff Medicated Cleansing BarPYRITHIONE ZINC 2%RoyceDerm LLC3b98a83d-9c3b-9522-e063-6294a90a70332025-08-05WarningsExact identifier
ndc (package): 85424-008-01
ndc (product): 85424-008
ndc11 (package): 85424000801
spl id: 3b98a83d-9c3c-9522-e063-6294a90a7033
spl set id: 3b98a83d-9c3b-9522-e063-6294a90a7033

Reported adverse events (FAERS/openFDA)#

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