NDC 79546-201 Mocheasu Alopecia-shampoo

Zinc Pyrithione, Salicylic Acid

NDC Product Information

Mocheasu Alopecia-shampoo with NDC 79546-201 is a a human over the counter drug product labeled by Somi T Na Co., Ltd. The generic name of Mocheasu Alopecia-shampoo is zinc pyrithione, salicylic acid. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Somi T Na 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.

Mocheasu Alopecia-shampoo 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 .3 g/100mL
  • SALICYLIC ACID .2 g/100mL

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.

  • POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • CYSTEINE (UNII: K848JZ4886)
  • SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • MORUS ALBA STEM (UNII: 05Y42QCG2T)
  • SALMON, UNSPECIFIED (UNII: 6122W2M0GB)
  • ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • LETTUCE (UNII: 5PO6NN3RRJ)
  • REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
  • ONION (UNII: 492225Q21H)
  • HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BETAINE (UNII: 3SCV180C9W)
  • ALCOHOL (UNII: 3K9958V90M)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • LAURYL BETAINE (UNII: Y4P927Q133)
  • TRIETHANOLAMINE COCOYL GLUTAMINATE (UNII: 2R6QKD2Y0M)
  • LAWSONIA INERMIS FLOWERING TOP (UNII: UF2093XE64)
  • MENTHOL (UNII: L7T10EIP3A)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • ALLANTOIN (UNII: 344S277G0Z)
  • URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)
  • LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • CABBAGE (UNII: GW0W1Y9I97)
  • WATER (UNII: 059QF0KO0R)
  • HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
  • MORUS ALBA LEAF (UNII: M8YIA49Q2P)
  • MORUS ALBA ROOT (UNII: CST1G9BZGD)
  • FIG (UNII: TGD87RII2U)

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: Somi T Na Co., Ltd
Labeler Code: 79546
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: 07-11-2020 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.

Mocheasu Alopecia-shampoo 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

Salicylic Acid 0.2%Zinc Pyrithione 0.3%

Purpose

Anti dandruff

Use

Hair loss symptom relief shampoo cleanses the scalp of the hair and helps the healthy hair by supplying nutrients as the main ingredient

Warnings

Wash it as soon as it gets into your eyes

Keep it out of reach of children

And keep it out of direct sunlight

Stop use and ask a doctor if irritation or rash occurs.

Directions

After fully wetting hair with water, apply an appropriate amount to hair and scalp, fuiiy lather and wash off with lukewarm water.

Inactive Ingredients

Water, Decyl Glucoside, Lauramidopropyl Betaine, Potassium Cocoyl Glycinate, Lauryl Betaine, Disodium Cocoamphodiacetate, Cocamide MEA, TEA-Cocoyl Glutaminate, Olea Europaea (Olive) Fruit Oil, Glycerin, Yucca Vera Leaf/Root Extract, Lawsonia Inermis (Henna) Extract, Menthol, Niacinamide, Allantoin, Hippophae Rhamnoides Fruit Extract, Urtica Dioica (Nettle) Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Crambe Abyssinica Seed Oil, Morus Alba Twig Extract, Morus Alba Leaf Extract, Morus Alba Root Extract, Ficus Carica (Fig) Fruit Extract, Salmon Egg Extract, Acorus Calamus Root Extract, Scutellaria Baicalensis Root Extract, Cysteine, Lactuca Scariola Sativa (Lettuce) Leaf Extract, Polygonum Multiflorum Root Extract, Brassica Oleracea Capitata (Cabbage) Leaf Extract, Allium Cepa (Onion) Bulb Extract, Sophora Flavescens Root Extract, Panax Ginseng Root Extract, Houttuynia Cordata Extract, Sodium Chloride, 1,2-Hexanediol, Betaine, Guar Hydroxypropyltrimonium Chloride, Alcohol, Cetearyl Alcohol, Polyquaternium-7, Dimethicone, Disodium EDTA

* Please review the disclaimer below.