NDC 50375-005 Daeng Gi Meo Ri Gounmo Hair Loss Care

Niacinamide

NDC Product Code 50375-005

NDC CODE: 50375-005

Proprietary Name: Daeng Gi Meo Ri Gounmo Hair Loss Care What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Niacinamide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.

NDC Code Structure

NDC 50375-005-01

Package Description: 300 mL in 1 BOTTLE, PUMP

NDC 50375-005-02

Package Description: 400 mL in 1 BOTTLE, PUMP

NDC Product Information

Daeng Gi Meo Ri Gounmo Hair Loss Care with NDC 50375-005 is a a human over the counter drug product labeled by Doori Cosmetics Co., Ltd.. The generic name of Daeng Gi Meo Ri Gounmo Hair Loss Care is niacinamide. 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 Hair Loss 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.

  • NIACINAMIDE .001 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)
  • DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
  • CHRYSANTHEMUM ZAWADSKII WHOLE (UNII: 8Z1G3DJ591)
  • REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
  • REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
  • LAURYL HYDROXYSULTAINE (UNII: 176KKP31OZ)
  • PURSLANE (UNII: M6S840WXG5)
  • MORUS ALBA BARK (UNII: 7O71A48NDP)
  • ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
  • ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • POMEGRANATE (UNII: 56687D1Z4D)
  • PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)

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
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: 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 Hair Loss Care Product Label Images

Daeng Gi Meo Ri Gounmo Hair Loss 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

Niacinamide 0.1%

Purpose

Hair Loss Care

Use

  • Helps prevent hair loss

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, Disodium Laureth Sulfosuccinate, Chrysanthemum Zawadskii Extract, Rehmannia Glutinosa Root Extract, Polygonum Multiflorum Root Extract, Lauryl Glucoside, Houttuynia Cordata Extract, Lauryl Hydroxysultaine, Fragrance, Portulaca Oleracea Extract, Morus Alba Bark Extract, Artemisia Vulgaris Extract, Eclipta Prostrata Extract, Cocamide MEA, Punica Granatum Fruit Extract, PEG-7 Glyceryl Cocoate, Citric Acid, PEG-120 Methyl Glucose Dioleate, Dimethiconol, Polyquaternium-10, TEA-Dodecylbenzenesulfonate, Sodium Citrate, Panthenol, Menthol, Salicylic Acid, Red Ginseng Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Panax Ginseng Root Extract, Tetrasodium EDTA, Disodium EDTA, Polyquaternium-7, Glycerin, Acorus Calamus Rhizome Water, Sodium Chloride, Butylene Glycol, Sodium Benzoate, Phenoxyethanol

* Please review the disclaimer below.