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

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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

01

ROYCEDERM SEBORRHEIC DERMATITIS PSORIASIS 
dermatitis cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83771-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE (UNII: 7NNO0D7S5M) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE0.15 g  in 100 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ELYMUS VIOLACEUS WHOLE (UNII: 05VL37FC3P)  
GANODERMA LUCIDUM STEM (UNII: U8PA41532G)  
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)  
NYCTANTHES ARBOR-TRISTIS WHOLE (UNII: FM5DVE2OJ1)  
MINT (UNII: FV98Z8GITP)  
EUPHORBIA HIRTA (UNII: L13YF113GN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83771-001-01100 mL in 1 CANISTER; Type 0: Not a Combination Product10/26/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00510/26/2023
Labeler - Inner Mongolia Green source pharmaceutical Products Co., LTD (699508923)
Establishment
NameAddressID/FEIBusiness Operations
Inner Mongolia Green source pharmaceutical Products Co., LTD699508923label(83771-001) , manufacture(83771-001)

Revised: 10/2023
Document Id: 08aee3eb-5140-9899-e063-6294a90a106c
Set id: 08aee3eb-513f-9899-e063-6294a90a106c
Version: 1
Effective Time: 20231027
 
Inner Mongolia Green source pharmaceutical Products Co., LTD