50375-007_Daeng gi meo ri gounmo dandruff care shampoo

Daeng gi meo ri gounmo dandruff care by

Drug Labeling and Warnings

Daeng gi meo ri gounmo dandruff care by is a Otc medication manufactured, distributed, or labeled by Doori Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAENG GI MEO RI GOUNMO DANDRUFF CARE- pyrithione zinc shampoo 
Doori Cosmetics Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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50375-007_Daeng gi meo ri gounmo dandruff care shampoo

Active ingredient

Zinc Pyrithione 0.3%

Purpose

Anti-dandruff

Use

• Helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Thoroughly wet hair from roots to ends lukewarm water. Lather moderate amounts of shampoo and massage scalp and hair using fingers or application.

Rinse with water to clean hair.

Inactive ingredients

Water, Chrysanthemum Zawadskii Extract, Acorus Calamus Rhizome Water, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Panax Ginseng Root Extract, Cocamidopropyl Betaine, Thuja Orientalis Leaf Extract, Morus Alba Bark Extract, Houttuynia Cordata Extract, Polygonum Multiflorum Root Extract , Tetrasodium EDTA, Rehmannia Glutinosa Root Extract, Portulaca Oleracea Extract, PEG-7 Glyceryl Cocoate, Fragrance, Panthenol, Cocamide MEA, Trihydroxystearin, Guar Hydroxypropyltrimonium Chloride, Salicylic Acid, Menthol, Dimethiconol, Artemisia Vulgaris Extract, TEA-Dodecylbenzenesulfonate, Sodium Citrate, Disodium EDTA, Betula Platyphylla Japonica Juice, Butylene Glycol, Glycerin, Hydrolyzed Keratin, Sodium Polynaphthalenesulfonate, Bacillus Ferment, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Rosmarinus Officinalis (Rosemary) Extract, Lavandula Angustifolia (Lavender) Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Centella Asiatica Extract, Poria Cocos Extract, Astragalus Membranaceus Root Extract, Sodium Benzoate, Potassium Sorbate

DAENG GI MEO RI GOUNMO DANDRUFF CARE 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50375-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.003 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CHRYSANTHEMUM ZAWADSKII WHOLE (UNII: 8Z1G3DJ591)
CALAMUS OIL (UNII: 5F9K5X640P)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
ASIAN GINSENG (UNII: CUQ3A77YXI)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)
MORUS ALBA BARK (UNII: 7O71A48NDP)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
EDETATE SODIUM (UNII: MP1J8420LU)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
PURSLANE (UNII: M6S840WXG5)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PANTHENOL (UNII: WV9CM0O67Z)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
SALICYLIC ACID (UNII: O414PZ4LPZ)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50375-007-01	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/05/2020	10/05/2020
2	NDC: 50375-007-02	400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/05/2020	10/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/05/2020	10/05/2020

Labeler - Doori Cosmetics Co., Ltd. (688227465)

Registrant - Doori Cosmetics Co., Ltd. (688227465)

Establishment
Name	Address	ID/FEI	Business Operations
Doori Cosmetics Co., Ltd.		688227465	manufacture(50375-007)

Revised: 9/2021

Document Id: cd26a38b-b014-446d-e053-2a95a90a60ca

34390-5

Set id: deb2761e-1f26-4085-96ec-d5ca92c7a901

Version: 5

Effective Time: 20210929