RoyceDerm Seborrheic Dermatitis Psoriasis by Inner Mongolia Green source pharmaceutical Products Co., LTD 83771-001 Complete

RoyceDerm Seborrheic Dermatitis Psoriasis by

Drug Labeling and Warnings

RoyceDerm Seborrheic Dermatitis Psoriasis by is a Otc medication manufactured, distributed, or labeled by Inner Mongolia Green source pharmaceutical Products Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROYCEDERM SEBORRHEIC DERMATITIS PSORIASIS- dermatitis cream cream 
Inner Mongolia Green source pharmaceutical Products Co., LTD

----------

83771-001 Complete

Active Ingredient

Ketoconazole 0.5%
Miconazole 0.15

Purpose

Antifungal

Seborrheic dermatitis & Psoriasis

Use

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

Warnings

For external use only

Do not use

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

Stop Use

if condition worsens or does notimprove after regular use as Directed

Ask Doctor

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

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

Directions

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

Store at room temperature and out of direct sunlight

Inactive ingredients

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

Questions

Visit www.roycederm.com

PRINCIPAL DISPLAY PANEL

ROYCEDERM SEBORRHEIC DERMATITIS PSORIASIS 
dermatitis cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83771-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE (UNII: 7NNO0D7S5M) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE	0.15 g  in 100 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ELYMUS VIOLACEUS WHOLE (UNII: 05VL37FC3P)
GANODERMA LUCIDUM STEM (UNII: U8PA41532G)
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)
EUPHORBIA HIRTA (UNII: L13YF113GN)
NYCTANTHES ARBOR-TRISTIS WHOLE (UNII: FM5DVE2OJ1)
MINT (UNII: FV98Z8GITP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83771-001-01	100 mL in 1 CANISTER; Type 0: Not a Combination Product	10/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/26/2023	04/27/2025

Labeler - Inner Mongolia Green source pharmaceutical Products Co., LTD (699508923)

Establishment
Name	Address	ID/FEI	Business Operations
Inner Mongolia Green source pharmaceutical Products Co., LTD		699508923	label(83771-001) , manufacture(83771-001)

Revised: 4/2025

Document Id: 33c172ec-c44a-65f6-e063-6394a90a3fe2

34390-5

Set id: 08aee3eb-513f-9899-e063-6294a90a106c

Version: 2

Effective Time: 20250427

 

Inner Mongolia Green