NDC 72850-0003 Goryeodyo Goyak

Ampelopsis Radix , Angelica Dahurica Root

NDC Product Code 72850-0003

NDC 72850-0003-1

Package Description: 4 g in 1 BOX

NDC Product Information

Goryeodyo Goyak with NDC 72850-0003 is a a human over the counter drug product labeled by Chunwoo Pharmaceutical Co., Ltd.. The generic name of Goryeodyo Goyak is ampelopsis radix , angelica dahurica root. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Chunwoo Pharmaceutical Co., Ltd.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Goryeodyo Goyak Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SCROPHULARIA BUERGERIANA ROOT 1.8 g/100g
  • SCUTELLARIA BAICALENSIS ROOT 7.5 g/100g
  • AMPELOPSIS JAPONICA TUBER 3.75 g/100g
  • ANGELICA GIGAS ROOT OIL 1.88 g/100g
  • RHUBARB 7.5 g/100g
  • ASTRAGALUS PROPINQUUS ROOT 1.88 g/100g
  • BLETILLA STRIATA TUBER 1.88 g/100g
  • REHMANNIA GLUTINOSA ROOT 1.88 g/100g
  • CINNAMON BARK OIL 1.88 g/100g
  • FRANKINCENSE 1.88 g/100g
  • MOMORDICA COCHINCHINENSIS SEED 1.88 g/100g
  • PAEONIA LACTIFLORA ROOT 1.88 g/100g
  • PHELLODENDRON CHINENSIS BARK 1.88 g/100g
  • MYRRH 1.88 g/100g
  • LEAD TETROXIDE 25 g/100g
  • SULFUR .1 g/100g
  • APRICOT KERNEL OIL 1.88 g/100g
  • ANGELICA DAHURICA ROOT 1.88 g/100g
  • YELLOW WAX 3.75 g/100g
  • CITRUS AURANTIUM FRUIT RIND .1 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MENTHOL (UNII: L7T10EIP3A)
  • CAMPHOR, (-)- (UNII: 213N3S8275)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Chunwoo Pharmaceutical Co., Ltd.
Labeler Code: 72850
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-19-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Goryeodyo Goyak Product Label Images

Goryeodyo Goyak Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Ampelopsis Radix 3.75% ------------------------------------------------------------ Boil, pus removerAngelica Dahurica Root 1.88% ------------------------------------------------------ Boil, pus removerAngelica Gigas Root 1.88% ---------------------------------------------------------- Boil, pus removerApricot Kernel 1.88% ---------------------------------------------------------------- Boil, pus removerAstragali Radix 1.88% ---------------------------------------------------------------- Boil, pus removerBletillae Rhizoma 1.88% ------------------------------------------------------------- Boil, pus removerCinnamon Bark 1.88% --------------------------------------------------------------- Boil, pus removerMomordicae Semen 1.88% --------------------------------------------------------- Boil, pus removerMyrrh 1.88% ------------------------------------------------------------------------- Boil, pus removerFrankincense 1.88% ------------------------------------------------------------------ Boil, pus removerPeony Root 1.88% ------------------------------------------------------------------- Boil, pus removerPhellodendron Bark 1.88% ---------------------------------------------------------- Boil, pus removerMinium 25% -------------------------------------------------------------------------- Boil, pus removerRehmannia Glutinosa Root 1.88% -------------------------------------------------- Boil, pus removerRhubarb 7.5% ------------------------------------------------------------------------ Boil, pus removerScrophularia Buergeriana Root 1.8% ------------------------------------------------- Boil, pus removerScutellariae Radix 7.5% --------------------------------------------------- Boil, pus removerYellow Beeswax 3.75% --------------------------------------------------------------- Boil, pus remover(Uprooting ointment 1g)Aurantii Pericarpium 0.1% ------------------------------------------------ Boil, pus removerSulfur 0.1% --------------------------------------------------------------------------- Boil, pus remover

Inactive Ingredient

-GoyakCamphor, Honey, Menthol, Menthyl Salicylate, Rice Oil-Uprooting OintmentHoney, Medical Soap, Rice Oil, Sucrose

Otc - Purpose

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

Otc - 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 eyesAsk a doctor before use■ if you are allergic to any ingredients of this product.■ if pregnant or breastfeedingWhen 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

* Please review the disclaimer below.

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