Goryeodyo Goyak

Ampelopsis Radix , Angelica Dahurica Root


Chunwoo Pharmaceutical Co., Ltd.
Human Otc Drug
NDC 72850-0003
Goryeodyo Goyak also known as Ampelopsis Radix , Angelica Dahurica Root is a human otc drug labeled by 'Chunwoo Pharmaceutical Co., Ltd.'. National Drug Code (NDC) number for Goryeodyo Goyak is 72850-0003. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Goryeodyo Goyak drug includes Ampelopsis Japonica Tuber - 3.75 g/100g Angelica Dahurica Root - 1.88 g/100g Angelica Gigas Root Oil - 1.88 g/100g Apricot Kernel Oil - 1.88 g/100g Astragalus Propinquus Root - 1.88 g/100g Bletilla Striata Tuber - 1.88 g/100g Cinnamon Bark Oil - 1.88 g/100g Citrus Aurantium Fruit Rind - .1 g/100g Frankincense - 1.88 g/100g Lead Tetroxide - 25 g/100g and more. The currest status of Goryeodyo Goyak drug is Active.

Drug Information:

Drug NDC: 72850-0003
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Goryeodyo Goyak
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Ampelopsis Radix , Angelica Dahurica Root
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Chunwoo Pharmaceutical Co., Ltd.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:AMPELOPSIS JAPONICA TUBER - 3.75 g/100g
ANGELICA DAHURICA ROOT - 1.88 g/100g
ANGELICA GIGAS ROOT OIL - 1.88 g/100g
APRICOT KERNEL OIL - 1.88 g/100g
ASTRAGALUS PROPINQUUS ROOT - 1.88 g/100g
BLETILLA STRIATA TUBER - 1.88 g/100g
CINNAMON BARK OIL - 1.88 g/100g
CITRUS AURANTIUM FRUIT RIND - .1 g/100g
FRANKINCENSE - 1.88 g/100g
LEAD TETROXIDE - 25 g/100g
MOMORDICA COCHINCHINENSIS SEED - 1.88 g/100g
MYRRH - 1.88 g/100g
PAEONIA LACTIFLORA ROOT - 1.88 g/100g
PHELLODENDRON CHINENSIS BARK - 1.88 g/100g
REHMANNIA GLUTINOSA ROOT - 1.88 g/100g
RHUBARB - 7.5 g/100g
SCROPHULARIA BUERGERIANA ROOT - 1.8 g/100g
SCUTELLARIA BAICALENSIS ROOT - 7.5 g/100g
SULFUR - .1 g/100g
YELLOW WAX - 3.75 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 19 Mar, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 10 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Chunwoo Pharmaceutical Co., Ltd.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000185375
N0000185371
N0000175629
N0000184306
M0000728
M0006342
M0016962
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:O2672197TF
1V63N2S972
3EYY3K7TBB
54JB35T06A
922OP8YUPF
00T5SH6SEJ
XE54U569EC
055456JHI7
R9XLF1R1WM
A4G39L7HN2
2T87O1UPVD
JC71GJ1F3L
3Z3866YW6P
2866QMZ434
1BEM3U6LQQ
G280W4MW6E
CYM875P4NW
7J95K7ID2S
70FD1KFU70
2ZA36H0S2V
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Non-Standardized Plant Allergenic Extract [EPC]
Non-Standardized Food Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Allergens [CS]
Dietary Proteins [CS]
Plant Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Allergens [CS]
Cell-mediated Immunity [PE]
Dietary Proteins [CS]
Increased Histamine Release [PE]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Plant Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
72850-0003-14 g in 1 BOX (72850-0003-1)19 Mar, 2019N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

■ boil and pus remover. ■ help reducing the pain from a boil

Product Elements:

Goryeodyo goyak ampelopsis radix , angelica dahurica root scrophularia buergeriana root scrophularia buergeriana root scutellaria baicalensis root scutellaria baicalensis root menthol ampelopsis japonica tuber ampelopsis japonica tuber angelica gigas root oil angelica gigas root oil rhubarb rhubarb astragalus propinquus root astragalus propinquus root bletilla striata tuber bletilla striata tuber rehmannia glutinosa root rehmannia glutinosa root cinnamon bark oil cinnamon bark oil frankincense frankincense momordica cochinchinensis seed momordica cochinchinensis seed paeonia lactiflora root paeonia lactiflora root phellodendron chinensis bark phellodendron chinensis bark myrrh myrrh lead tetroxide lead tetroxide sulfur sulfur apricot kernel oil apricot kernel oil angelica dahurica root angelica dahurica root yellow wax yellow wax citrus aurantium fruit rind citrus aurantium fruit rind camphor, (-)-

Indications and 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 and Administration:

For external use only

Package Label Principal Display Panel:

Label


Comments/ Reviews:

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