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NDC 72850-0003-01 Goryeodyo Goyak 3.75; 1.88; 1.88; 1.88; 1.88; 1.88; 1.88; .1; 1.88; 25; 1.88; 1.88; 1.88; 1.88; 1.88; 7.5; 1.8; 7.5; .1; 3.75 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g Details

Goryeodyo Goyak 3.75; 1.88; 1.88; 1.88; 1.88; 1.88; 1.88; .1; 1.88; 25; 1.88; 1.88; 1.88; 1.88; 1.88; 7.5; 1.8; 7.5; .1; 3.75 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g

Goryeodyo Goyak is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Chunwoo Pharmaceutical Co., Ltd.. The primary component is AMPELOPSIS JAPONICA TUBER; ANGELICA DAHURICA ROOT; ANGELICA GIGAS ROOT OIL; APRICOT KERNEL OIL; ASTRAGALUS PROPINQUUS ROOT; BLETILLA STRIATA TUBER; CINNAMON BARK OIL; CITRUS AURANTIUM FRUIT RIND; FRANKINCENSE; LEAD TETROXIDE; MOMORDICA COCHINCHINENSIS SEE.

Product Information

NDC	72850-0003
Product ID	72850-0003_84835dc0-e401-37e2-e053-2a91aa0a761c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Goryeodyo Goyak
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ampelopsis Radix , Angelica Dahurica Root
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	3.75; 1.88; 1.88; 1.88; 1.88; 1.88; 1.88; .1; 1.88; 25; 1.88; 1.88; 1.88; 1.88; 1.88; 7.5; 1.8; 7.5; .1; 3.75
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g
Substance Name	AMPELOPSIS JAPONICA TUBER; ANGELICA DAHURICA ROOT; ANGELICA GIGAS ROOT OIL; APRICOT KERNEL OIL; ASTRAGALUS PROPINQUUS ROOT; BLETILLA STRIATA TUBER; CINNAMON BARK OIL; CITRUS AURANTIUM FRUIT RIND; FRANKINCENSE; LEAD TETROXIDE; MOMORDICA COCHINCHINENSIS SEE
Labeler Name	Chunwoo Pharmaceutical Co., Ltd.
Pharmaceutical 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]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72850-0003-01 (72850000301)

Pricing Information	N/A
NDC Package Code	72850-0003-1
Billing NDC	72850000301
Package	4 g in 1 BOX (72850-0003-1)
Marketing Start Date	2019-03-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8483f19c-36b9-278d-e053-2a91aa0a1285 Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

-Goyak

Camphor, Honey, Menthol, Menthyl Salicylate, Rice Oil

-Uprooting Ointment

Honey, Medical Soap, Rice Oil, Sucrose

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

keep out of reach of the children

SPL UNCLASSIFIED SECTION

■ 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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GORYEODYO GOYAK

ampelopsis radix , angelica dahurica root ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72850-0003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SCROPHULARIA BUERGERIANA ROOT (UNII: CYM875P4NW) (SCROPHULARIA BUERGERIANA ROOT - UNII:CYM875P4NW)	SCROPHULARIA BUERGERIANA ROOT	1.8 g in 100 g
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) (SCUTELLARIA BAICALENSIS ROOT - UNII:7J95K7ID2S)	SCUTELLARIA BAICALENSIS ROOT	7.5 g in 100 g
AMPELOPSIS JAPONICA TUBER (UNII: O2672197TF) (AMPELOPSIS JAPONICA TUBER - UNII:O2672197TF)	AMPELOPSIS JAPONICA TUBER	3.75 g in 100 g
ANGELICA GIGAS ROOT OIL (UNII: 3EYY3K7TBB) (ANGELICA GIGAS ROOT OIL - UNII:3EYY3K7TBB)	ANGELICA GIGAS ROOT OIL	1.88 g in 100 g
RHUBARB (UNII: G280W4MW6E) (RHUBARB - UNII:G280W4MW6E)	RHUBARB	7.5 g in 100 g
ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF) (ASTRAGALUS PROPINQUUS ROOT - UNII:922OP8YUPF)	ASTRAGALUS PROPINQUUS ROOT	1.88 g in 100 g
BLETILLA STRIATA TUBER (UNII: 00T5SH6SEJ) (BLETILLA STRIATA TUBER - UNII:00T5SH6SEJ)	BLETILLA STRIATA TUBER	1.88 g in 100 g
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) (REHMANNIA GLUTINOSA ROOT - UNII:1BEM3U6LQQ)	REHMANNIA GLUTINOSA ROOT	1.88 g in 100 g
CINNAMON BARK OIL (UNII: XE54U569EC) (CINNAMON BARK OIL - UNII:XE54U569EC)	CINNAMON BARK OIL	1.88 g in 100 g
FRANKINCENSE (UNII: R9XLF1R1WM) (FRANKINCENSE - UNII:R9XLF1R1WM)	FRANKINCENSE	1.88 g in 100 g
MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD) (MOMORDICA COCHINCHINENSIS SEED - UNII:2T87O1UPVD)	MOMORDICA COCHINCHINENSIS SEED	1.88 g in 100 g
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) (PAEONIA LACTIFLORA ROOT - UNII:3Z3866YW6P)	PAEONIA LACTIFLORA ROOT	1.88 g in 100 g
PHELLODENDRON CHINENSIS BARK (UNII: 2866QMZ434) (PHELLODENDRON CHINENSIS BARK - UNII:2866QMZ434)	PHELLODENDRON CHINENSIS BARK	1.88 g in 100 g
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)	MYRRH	1.88 g in 100 g
LEAD TETROXIDE (UNII: A4G39L7HN2) (LEAD TETROXIDE - UNII:A4G39L7HN2)	LEAD TETROXIDE	25 g in 100 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	0.1 g in 100 g
APRICOT KERNEL OIL (UNII: 54JB35T06A) (APRICOT KERNEL OIL - UNII:54JB35T06A)	APRICOT KERNEL OIL	1.88 g in 100 g
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) (ANGELICA DAHURICA ROOT - UNII:1V63N2S972)	ANGELICA DAHURICA ROOT	1.88 g in 100 g
YELLOW WAX (UNII: 2ZA36H0S2V) (YELLOW WAX - UNII:2ZA36H0S2V)	YELLOW WAX	3.75 g in 100 g
CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7) (CITRUS AURANTIUM FRUIT RIND - UNII:055456JHI7)	CITRUS AURANTIUM FRUIT RIND	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MENTHOL (UNII: L7T10EIP3A)
CAMPHOR, (-)- (UNII: 213N3S8275)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72850-0003-1	4 g in 1 BOX; Type 0: Not a Combination Product	03/19/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/19/2019

Labeler - Chunwoo Pharmaceutical Co., Ltd. (688729065)

Registrant - Chunwoo Pharmaceutical Co., Ltd. (688729065)

Name	Address	ID/FEI	Business Operations
Establishment
Chunwoo Pharmaceutical Co., Ltd.		688729065	manufacture(72850-0003) , label(72850-0003)

Revised: 3/2019

Document Id: 84835dc0-e401-37e2-e053-2a91aa0a761c

Set id: 8483f19c-36b9-278d-e053-2a91aa0a1285

Version: 1

Effective Time: 20190320

Search by Drug Name or NDC

Goryeodyo Goyak 3.75; 1.88; 1.88; 1.88; 1.88; 1.88; 1.88; .1; 1.88; 25; 1.88; 1.88; 1.88; 1.88; 1.88; 7.5; 1.8; 7.5; .1; 3.75 g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g; g/100g

Product Information

Package

Package Images

NDC 72850-0003-01 (72850000301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8483f19c-36b9-278d-e053-2a91aa0a1285 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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