Label: PURESKIN MOLLUSCUM TREATMENT- molluscum treatment liquid

  • 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 13, 2023

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  • Active Ingredient

    Thuja Occidentalis 5x HPUS

  • Purpose

    Molluscum Symptom Relief

  • Use

    Relief for Molluscum Contagiosum symptoms, such as itch, bumps, and lesions.

  • Warnings

  • Do not use

    On open skin wounds

  • 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

    If you are allergic to this product.
    If symptoms persist for over 7 days or worsen, consult your physician.
    If you are pregnant or breast-feeding
    You become pregnant or are planning to become pregnant while using this product

  • Ask Doctor

    If you are allergic to this product.
    If symptoms persist for over 7 days or worsen, consult your physician.
    If you are pregnant or breast-feeding
    You become pregnant or are planning to become pregnant while using this product

  • Keep Out Of Reach Of Children

    Keep out of reach of children.In case of ingestion, call Poison Control Center hotline immediately or seek medical help.

  • Directions

    Wash and dry the affected area.
    Apply the liquid to the bumps 3-4 times a day and let it dry.
    Continue the treatment daily until molluscum contagiosum disappears.

  • Other information

    store at 15-25 ℃

  • Inactive ingredients

    Water
    Glycerin
    Brucea Javanica
    Cyperus Cyperinus
    Equisetum
    Peucedanum
    Isatis Tinctoria Root

  • Questions

    info@pureskinsupport.com
    www.pureskinsupport.com

  • PRINCIPAL DISPLAY PANEL

    144

  • INGREDIENTS AND APPEARANCE
    PURESKIN MOLLUSCUM TREATMENT 
    molluscum treatment liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83565-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786) THUJA OCCIDENTALIS LEAF5 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYPERUS CYPERINUS WHOLE (UNII: ZJ537UL75O)  
    WATER (UNII: 059QF0KO0R)  
    PEUCEDANUM OSTRUTHIUM LEAF (UNII: 86P27YRR6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISATIS TINCTORIA ROOT (UNII: 8S10GFI6DX)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    BRUCEA JAVANICA WHOLE (UNII: Z4CCI5NZ66)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83565-002-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02807/13/2023
    Labeler - Stellans Inc. (111157321)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stellans Inc.111157321manufacture(83565-002) , label(83565-002)
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