Label: PURESKIN SEBORRHEIC DERMATITIS ECZEMA CREAM- seborrheic dermatitis eczema cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 8, 2023

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  • Active Ingredient

    Ketoconazole 0.5%

  • Purpose

    seborrheic dermatitis, eczema

  • Use

    USES for relief of skin itching, irritation, redness, flaking and scaling associated with seborrheic dermatitis, eczema, folliculitis, or psoriasis, and to help prevent symptom recurrence.

  • Warnings

    For external use only.

  • Do not use

    On open skin wounds
    In children less than 6 months of age.

  • When Using

    Avoid contact with eyes. If contact occurs, rinse the eyes immediately with water.
    Keep out of the reach of young children.

  • Stop Use

    Condition worsens or doesn’t improve after regular use of the product as directed.
    You become pregnant, or are planning to become pregnant, while using the product.

  • Ask Doctor

    Condition worsens or doesn’t improve after regular use of the product as directed.
    You become pregnant, or are planning to become pregnant, while using the product.

  • Keep Out Of Reach Of Children

    Keep out reach of children.

  • Directions

    Clean the affected area with warm water and dry thoroughly.
    Apply a thin layer over the affected area two to three times daily and gently massage it 2 minutes, repeat 3 to 5 days after symptoms disappear to control recurrence.
    Children should use it under the supervision of adults.

  • Other information

    store at 20-25 ℃

  • Inactive ingredients

    Glycerin, Sodium Hyaluronate, Salicylic Acid,
    Rhinacanthus Nasutus Leaf, Heba Violae, Euphorbia Hirta L., Murraya Exotica L., Mentha Canadensis L., Cortexdictamnil, Sophora Flavescens Root, Cnidium Monnieri (L.) Cusson, Smilax Glabra Rhizome, Mosla Cavaleriei H.Lv.,, Phellodendron Amurense Rupr., Fischereuphorbia Root, Gleditsia Sinensis Thorn, Kochia Scoparia, Chlorhexidine Acetate, Stemona Tuberosa Lour

  • Questions

    info@pureskinsupport.com
    www.pureskinsupport.com

  • PRINCIPAL DISPLAY PANEL

    0102

  • INGREDIENTS AND APPEARANCE
    PURESKIN SEBORRHEIC DERMATITIS ECZEMA CREAM 
    seborrheic dermatitis eczema cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83565-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    RHINACANTHUS NASUTUS LEAF (UNII: 97OQD55S9I)  
    DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
    MOSLA CAVALERIEI WHOLE (UNII: 05O8B64OS2)  
    GLEDITSIA SINENSIS THORN (UNII: 26LKE578NY)  
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    EUPHORBIA HIRTA LEAF (UNII: 243K8QF0MS)  
    MURRAYA PANICULATA LEAFY TWIG (UNII: VO9X9681W9)  
    MENTHA CANADENSIS WHOLE (UNII: J1BO4MHT2L)  
    CNIDIUM MONNIERI WHOLE (UNII: GYR30735RE)  
    BASSIA SCOPARIA FRUIT (UNII: 04W97Z676Y)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    SMILAX GLABRA TUBER (UNII: PES3YXA3LR)  
    STEMONA TUBEROSA WHOLE (UNII: 9373ZOT316)  
    PHELLODENDRON AMURENSE WHOLE (UNII: 3OZN5NGR9L)  
    EUPHORBIA FISCHERIANA ROOT (UNII: R4DRG4762Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    VIOLA ADUNCA WHOLE (UNII: 26Z8E4RZ3Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83565-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00507/07/2023
    Labeler - Stellans Inc. (111157321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stellans Inc.111157321label(83565-001) , manufacture(83565-001)
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