RoyceDerm Seborrheic Dermatitis Psoriasis

Manufacturer
Inner Mongolia Green source pharmaceutical Products Co., LTD
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:23:01

Label at a glance#

ProductRoyceDerm Seborrheic Dermatitis Psoriasis
Active ingredientMICONAZOLE, KETOCONAZOLE
Label structure13 sections

Dosage and administration

apply a small amount to the problem areas withcircular motions for 3 minutes till the skin absorbs the cream.apply it 2-3 times a day for the best result continue to use for 3-5 days after symptoms resolve to preventa recurrence Do not use it on children under 2 years of age unless directedby a doctor.

Storage and handling

Store at room temperature and out of direct sunlight

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketoconazole 0.5%
Miconazole 0.15

Purpose

OTC - PURPOSE SECTION

Antifungal

Seborrheic dermatitis & Psoriasis

Use

INDICATIONS & USAGE SECTION

Relieves and helps prevent recurrence of skin and/orscalp: itching, flaking, scaling, redness, and irritation associatedwith psoriasis and seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use it on children under 2 years of age unless directedby a doctor.

Stop Use

OTC - STOP USE SECTION

if condition worsens or does notimprove after regular use as Directed

Ask Doctor

OTC - ASK DOCTOR SECTION

if you are allergic to ingredients in thisproductWhen using this product avoid contact with eyes. lf contactoccurs, rinse the eyes thoroughly with water.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

apply a small amount to the problem areas withcircular motions for 3 minutes till the skin absorbs the cream.apply it 2-3 times a day for the best result

continue to use for 3-5 days after symptoms resolve to preventa recurrence
Do not use it on children under 2 years of age unless directedby a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature and out of direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, BORNEOL, SOPHORAFLAVESCENS ROOT, CNIDIUM MONNIERI FRUIT, KOCHIASCOPARIA POLLEN,DICTAMNUS DASYCARPUS ROOTSMILAX GLABRA WHOLE

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83771-001-012025-04-27C16284748780-12cef2736-abdd-d83d-e063-dadaa90ab31f08aee3eb-513f-9899-e063-6294a90a106c
83771-001-012025-01-30C16284748780-12cef2736-abdd-d83d-e063-dadaa90ab31f08aee3eb-513f-9899-e063-6294a90a106c

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83771-00183771-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
33c172ec-c44a-65f6-e063-6394a90a3fe208aee3eb-513f-9899-e063-6294a90a106c2025-04-27WarningsExact identifier
spl set id: 08aee3eb-513f-9899-e063-6294a90a106c

Reported adverse events (FAERS/openFDA)#

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