Label: CHUN-SHIM HAEDOKSAN- rehmannia glutinosa root powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 17, 2014

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  • ACTIVE INGREDIENT

    REHMANNIA GLUTINOSA ROOT


  • INACTIVE INGREDIENT

    poris cocos, alisma canaliculatum, gypsum, anemarrhena asphodeloides, ostericum koreanum, aralia continentalis, schizonepeta tenuifolia, saposhnikovia divaricata, forsythia viridissima, lonicera japonica, arctium lappa

  • PURPOSE

    Medicine for intractable skin disease. (e.g. Psoriasis, Atopy, Eczema, Dyshidrotic eczema, Acne, Hives, Seborrheic dermatitis, Leucoplakia, etc)


  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    intake 2 spoons (under the age 10, spoon) 2~3 times daily before or after a meal


  • WARNINGS

    1) avoid direct sun exposure, keep it refrigerated or in cooler places
    2) gently tap on the packaging a few times before intake

  • DOSAGE & ADMINISTRATION

    for oral use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    CHUN-SHIM HAEDOKSAN 
    rehmannia glutinosa root powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69245-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) (REHMANNIA GLUTINOSA ROOT - UNII:1BEM3U6LQQ) REHMANNIA GLUTINOSA ROOT5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)  
    FU LING (UNII: XH37TWY5O4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69245-1001-1300 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/08/2013
    Labeler - HAMABIO Co., Ltd. (690257191)
    Registrant - HAMABIO Co., Ltd. (690257191)
    Establishment
    NameAddressID/FEIBusiness Operations
    HAMABIO Co., Ltd.690257191manufacture(69245-1001)
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