Label: ROYCEDERM SEBORRHEIC DERMATITIS PSORIASIS- dermatitis cream cream

  • NDC Code(s): 83771-001-01
  • Packager: Inner Mongolia Green source pharmaceutical Products Co., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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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

  • INGREDIENTS AND APPEARANCE
    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)
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