NDC 80315-001 Dr.graft

Scalp Shampoo

NDC Product Information

Dr.graft with NDC 80315-001 is a a human over the counter drug product labeled by Medicosbiotech. Inc. The generic name of Dr.graft is scalp shampoo. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Medicosbiotech. Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Dr.graft 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.

  • SALICYLIC ACID .78 g/300mL
  • MENTHOL .936 g/300mL
  • PANTHENOL .624 g/300mL

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)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)

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: Medicosbiotech. Inc
Labeler Code: 80315
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: 08-28-2020 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.

Dr.graft Product Label Images

Dr.graft 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(S)

Salicylic Acid 0.25%Menthol 0.3%Panthenol 0.2%

Purpose

Purpose: Anti-hair loss

Use

 Shampoo for hair loss control Relieve hair loss symptoms Not a medicine for the prevention and treatment of diseases

Warnings

 For external use only. Keep out of reach of children. In case of having side effects such as red rash, swollenness and/or itching while using the product, or in case such symptoms appear by direct sunlight after using it, consult a dermatologist immediately. Do not apply the product on scar, eczema or dermatitis. In contact with eyes rinse immediately with plenty of water If not washed off with water after use, it may cause hair loss or discoloration.

Otc - Keep Out Of Reach Of Children

 Keep out of reach of children.

Directions

 Take an appropriate amount of the product on the wet hair, massage it lightly on the hair, and then wash it off with water.

Other Information

 Store in room temperature 0~30℃ Avoid direct sunlight

Inactive Ingredients

Water, Disodium Laureth Sulfosuccinate, Cocamidopropyl Betaine, Urtica Dioica (Nettle) Extract,Cocamide MIPA, PEG-7 Glyceryl Cocoate, Salicylic Acid, Houttuynia Cordata Extract, Butylene Glycol,1,2-Hexanediol, Ethylhexylglycerin, Hydrolyzed Silk, Hydrolyzed Collagen, Hydrolyzed Keratin,Copper Tripeptide-1, Panax Ginseng Root Extract, Morus Alba Bark Extract,Cnidium Officinale Root Extract, Acorus Calamus Root Extract, sh-Polypeptide-11, sh-Polypeptide-1,sh-Oligo peptide-2, sh-Polypeptide-3, sh-Polypeptide-4, sh-Polypep tide-22, sh-Polypeptide-9,Lecithin, Sodium Phosphate, Pentylene Glycol, Panthenol, Menthol, Tocopheryl Acetate,Polyquaternium-10, PEG-150 Distearate, Caprylyl Glycol, Disodium EDTA, Citric Acid, Fragrance

* Please review the disclaimer below.