Label: ROYCEDERM SEBORRHEIC DERMATITIS PSORIASIS SHAMPOO.- roycederm seborrheic dermatitis psoriasis shampoo shampoo

  • NDC Code(s): 84746-002-01
  • Packager: Shandong Yuyaotang Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 19, 2024

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  • Active Ingredient

    Salicylic acid 3%

  • Purpose

    Seborrheic dermatitis and psoriasis.

  • Use

    Relieves and helps prevent recurrence of scalp: itching, flaking, scaling, redness and irritation associated with psoriasis and seborrheic dermatitis.

  • Warnings

    For external use only.

  • Do not use

    Do not use it on children under 12 years of age unless directed by a doctor.

  • When Using

    avoid contacwith eyes. lf contact occurs, rinse theeyes thoroughly with water.

  • Stop Use

    if conditionworsens or does not improve afterregular use as directed

  • Ask Doctor

    if you areallergic to ingredients in this product

  • Keep Oot Of Reach Of Children

    Do not use it on children under 12 years of age unless directed by a doctor.

  • Directions

    Apply shampoo & massage into the scalp，Leave in hair for 3-5 minutes to allow maximum absorption.Rinse and repeat as needed，Use daily for best results.Do not use it on children under 12 years of age unless directed by a doctor.

  • Other information

    Store at room temperature and out of direct sunlight

  • Inactive ingredients

    Water (Agua), Artemisia Extract, Fleeceflower Root, Cnidium Monnieri, Kochia Scoparia Gleditsia Sinensis, Typhonium Giganteum Eng, Stemona Tuberosa, Rhizoma Smilacis Glabrae, Borneol, Menthol, Fragrance,Cocamide MEA, Citric Acid, Guar Gum，Ethylene Glycol Stearate

  • Questions

    Visit www.roycederm.com

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ROYCEDERM SEBORRHEIC DERMATITIS PSORIASIS SHAMPOO. 
    roycederm seborrheic dermatitis psoriasis shampoo shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84746-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COPTIS TEETA ROOT (UNII: A92YL7456Q)  
    STEMONA TUBEROSA WHOLE (UNII: 9373ZOT316)  
    CNIDIUM MONNIERI WHOLE (UNII: GYR30735RE)  
    BORNEOL (UNII: M89NIB437X)  
    MENTHOL (UNII: L7T10EIP3A)  
    FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
    SAUROMATUM GIGANTEUM WHOLE (UNII: C61Y66MY4H)  
    BASSIA SCOPARIA WHOLE (UNII: 240G38P85Z)  
    GUAR GUM (UNII: E89I1637KE)  
    GLYCOL CETEARATE (UNII: YHX98F77PB)  
    ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84746-002-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03209/19/2024
    Labeler - Shandong Yuyaotang Pharmaceutical Co., Ltd (974645696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Yuyaotang Pharmaceutical Co., Ltd974645696manufacture(84746-002)
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