NDC 50375-007 Daeng Gi Meo Ri Gounmo Dandruff Care

Pyrithione Zinc

NDC Product Code 50375-007

NDC 50375-007-01

Package Description: 300 mL in 1 BOTTLE, PUMP

NDC 50375-007-02

Package Description: 400 mL in 1 BOTTLE, PUMP

NDC Product Information

Daeng Gi Meo Ri Gounmo Dandruff Care with NDC 50375-007 is a a human over the counter drug product labeled by Doori Cosmetics Co., Ltd.. The generic name of Daeng Gi Meo Ri Gounmo Dandruff Care is pyrithione zinc. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Doori Cosmetics Co., Ltd.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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.

Daeng Gi Meo Ri Gounmo Dandruff Care 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.

  • PYRITHIONE ZINC .003 g/mL

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.

  • 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)

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.
  • 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: Doori Cosmetics Co., Ltd.
Labeler Code: 50375
FDA Application Number: part358H What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 10-05-2020 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: 12-31-2021 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.

Daeng Gi Meo Ri Gounmo Dandruff Care Product Label Images

Daeng Gi Meo Ri Gounmo Dandruff Care 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

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.

Otc - When Using

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

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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

* Please review the disclaimer below.