Label: GORYEODYO GOYAK- ampelopsis radix , angelica dahurica root ointment

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 20, 2019

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  • ACTIVE INGREDIENT

    Ampelopsis Radix 3.75% ------------------------------------------------------------ Boil, pus remover

    Angelica Dahurica Root 1.88% ------------------------------------------------------ Boil, pus remover

    Angelica Gigas Root 1.88% ---------------------------------------------------------- Boil, pus remover

    Apricot Kernel 1.88% ---------------------------------------------------------------- Boil, pus remover

    Astragali Radix 1.88% ---------------------------------------------------------------- Boil, pus remover

    Bletillae Rhizoma 1.88% ------------------------------------------------------------- Boil, pus remover

    Cinnamon Bark 1.88% --------------------------------------------------------------- Boil, pus remover

    Momordicae Semen 1.88% --------------------------------------------------------- Boil, pus remover

    Myrrh 1.88% ------------------------------------------------------------------------- Boil, pus remover

    Frankincense 1.88% ------------------------------------------------------------------ Boil, pus remover

    Peony Root 1.88% ------------------------------------------------------------------- Boil, pus remover

    Phellodendron Bark 1.88% ---------------------------------------------------------- Boil, pus remover

    Minium 25% -------------------------------------------------------------------------- Boil, pus remover

    Rehmannia Glutinosa Root 1.88% -------------------------------------------------- Boil, pus remover

    Rhubarb 7.5% ------------------------------------------------------------------------ Boil, pus remover

    Scrophularia Buergeriana Root 1.8% ------------------------------------------------- Boil, pus remover

    Scutellariae Radix 7.5% --------------------------------------------------- Boil, pus remover

    Yellow Beeswax 3.75% --------------------------------------------------------------- Boil, pus remover

    (Uprooting ointment 1g)

    Aurantii Pericarpium 0.1% ------------------------------------------------ Boil, pus remover

    Sulfur 0.1% --------------------------------------------------------------------------- Boil, pus remover

  • INACTIVE INGREDIENT

    -Goyak

    Camphor, Honey, Menthol, Menthyl Salicylate, Rice Oil

    -Uprooting Ointment

    Honey, Medical Soap, Rice Oil, Sucrose

  • PURPOSE

    ■ Boil and pus remover. ■ Help reducing the pain from a boil

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    ■ when applying the plaster, melt the dark brown plaster with hand heat and knead it twice as big as the affected area. (If you are in cold place, put it on oil paper and melt it with match, candle and etc. for 5 to 10 seconds to help it stick well.)

    ■ before festering, attach the plaster only to cover the affected area.

    ■ when a pus or a boil is festering, insert an uprooting ointment into the area and attach the plaster on it.

    ■ Change to a new plaster after a day or two while symptom persists.

  • WARNINGS

    For external use only
    Do not use

    ■ if you are under 7

    ■ in or near eyes

    Ask a doctor before use

    ■ if you are allergic to any ingredients of this product.

    ■ if pregnant or breastfeeding

    When using this product

    ■ avoid eating greasy food; pork, herring, mackerel, and etc.

    Stop use and ask a doctor if

    ■ rash, itching or excessive skin irritation develops

    ■ symptoms persist for more than 7 days or clear up and occur again within a few days

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GORYEODYO GOYAK 
    ampelopsis radix , angelica dahurica root ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72850-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SCROPHULARIA BUERGERIANA ROOT (UNII: CYM875P4NW) (SCROPHULARIA BUERGERIANA ROOT - UNII:CYM875P4NW) SCROPHULARIA BUERGERIANA ROOT1.8 g  in 100 g
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) (SCUTELLARIA BAICALENSIS ROOT - UNII:7J95K7ID2S) SCUTELLARIA BAICALENSIS ROOT7.5 g  in 100 g
    AMPELOPSIS JAPONICA TUBER (UNII: O2672197TF) (AMPELOPSIS JAPONICA TUBER - UNII:O2672197TF) AMPELOPSIS JAPONICA TUBER3.75 g  in 100 g
    ANGELICA GIGAS ROOT OIL (UNII: 3EYY3K7TBB) (ANGELICA GIGAS ROOT OIL - UNII:3EYY3K7TBB) ANGELICA GIGAS ROOT OIL1.88 g  in 100 g
    RHUBARB (UNII: G280W4MW6E) (RHUBARB - UNII:G280W4MW6E) RHUBARB7.5 g  in 100 g
    ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF) (ASTRAGALUS PROPINQUUS ROOT - UNII:922OP8YUPF) ASTRAGALUS PROPINQUUS ROOT1.88 g  in 100 g
    BLETILLA STRIATA TUBER (UNII: 00T5SH6SEJ) (BLETILLA STRIATA TUBER - UNII:00T5SH6SEJ) BLETILLA STRIATA TUBER1.88 g  in 100 g
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) (REHMANNIA GLUTINOSA ROOT - UNII:1BEM3U6LQQ) REHMANNIA GLUTINOSA ROOT1.88 g  in 100 g
    CINNAMON BARK OIL (UNII: XE54U569EC) (CINNAMON BARK OIL - UNII:XE54U569EC) CINNAMON BARK OIL1.88 g  in 100 g
    FRANKINCENSE (UNII: R9XLF1R1WM) (FRANKINCENSE - UNII:R9XLF1R1WM) FRANKINCENSE1.88 g  in 100 g
    MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD) (MOMORDICA COCHINCHINENSIS SEED - UNII:2T87O1UPVD) MOMORDICA COCHINCHINENSIS SEED1.88 g  in 100 g
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) (PAEONIA LACTIFLORA ROOT - UNII:3Z3866YW6P) PAEONIA LACTIFLORA ROOT1.88 g  in 100 g
    PHELLODENDRON CHINENSIS BARK (UNII: 2866QMZ434) (PHELLODENDRON CHINENSIS BARK - UNII:2866QMZ434) PHELLODENDRON CHINENSIS BARK1.88 g  in 100 g
    MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH1.88 g  in 100 g
    LEAD TETROXIDE (UNII: A4G39L7HN2) (LEAD TETROXIDE - UNII:A4G39L7HN2) LEAD TETROXIDE25 g  in 100 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.1 g  in 100 g
    APRICOT KERNEL OIL (UNII: 54JB35T06A) (APRICOT KERNEL OIL - UNII:54JB35T06A) APRICOT KERNEL OIL1.88 g  in 100 g
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) (ANGELICA DAHURICA ROOT - UNII:1V63N2S972) ANGELICA DAHURICA ROOT1.88 g  in 100 g
    YELLOW WAX (UNII: 2ZA36H0S2V) (YELLOW WAX - UNII:2ZA36H0S2V) YELLOW WAX3.75 g  in 100 g
    CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7) (CITRUS AURANTIUM FRUIT RIND - UNII:055456JHI7) CITRUS AURANTIUM FRUIT RIND0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    CAMPHOR, (-)- (UNII: 213N3S8275)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72850-0003-14 g in 1 BOX; Type 0: Not a Combination Product03/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/19/2019
    Labeler - Chunwoo Pharmaceutical Co., Ltd. (688729065)
    Registrant - Chunwoo Pharmaceutical Co., Ltd. (688729065)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chunwoo Pharmaceutical Co., Ltd.688729065manufacture(72850-0003) , label(72850-0003)