NDC 74997-0016 W.skin Anti Hair Loss

Zinc Pyrithione, Dexpanthenol, Salicylic Acid

NDC Product Code 74997-0016

NDC 74997-0016-1

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

W.skin Anti Hair Loss with NDC 74997-0016 is a a human over the counter drug product labeled by J&j Company. The generic name of W.skin Anti Hair Loss is zinc pyrithione, dexpanthenol, salicylic acid. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: J&j Company

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.

W.skin Anti Hair Loss 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 .312 g/100mL
  • SALICYLIC ACID .2 g/100mL
  • DEXPANTHENOL .5 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: J&j Company
Labeler Code: 74997
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: 05-08-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

W.skin Anti Hair Loss Product Label Images

W.skin Anti Hair Loss 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

Otc - Active Ingredient

Zinc Pyrithione 0.312

Dexpanthenol 0.5

Salicylic acid 0.2

Inactive Ingredient

Water, Sodium Laureth Sulfate, Disodium Cocoamphodiacetate, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Butylene Glycol, Glycerin, Hexylene Glycol, Alcohol, ScutellariaBaicalensis Root Extract, CynanchumAtratum Extract, Stellaria Media (Chickweed) Extract, Nelumbo Nucifera Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Inula Britannica Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Paeonia Suffruticosa Root Extract, Arctium Lappa Root Extract, Pueraria Lobata Root Extract, Polygonum Cuspidatum Root Extract, Centella Asiatica Extract, Sesamum Indicum (Sesame) Seed Extract, Glycine Soja (Soybean) Seed Extract, Solanum Melongena (Eggplant) Fruit Extract, Morus Alba Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Allium Sativum (Garlic) Bulb Extract, Allium Cepa (Onion) Bulb Extract, Phaseolus Angularis Seed Extract, Panax Ginseng Root Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Extract, Camellia Sinensis Leaf Extract, LysimachiaFoenum-graecum Extract, Theobroma Cacao (Cocoa) Seed Extract, Ecklonia Cava Extract, Codium Tomentosum Extract, GelidiumCartilagineum Extract, HizikiaFusiforme Extract, Laminaria Japonica Extract, Undaria Pinnatifida Extract, Cordyceps militaris extract, Dexpanthenol, Fragrance, Methylpropanediol, Trihydroxystearin, Myristyl Alcohol, Stearyl Alcohol, Sodium Chloride, Cetyl Alcohol, Guar Hydroxypropyltrimonium Chloride, Caprylyl Glycol, Zinc Pyrithione, Salicylic Acid, Carbomer, Triethanolamine, Benzyl Glycol, Hydroxyethyl Urea, Sodium Citrate, Citric Acid, Sodium Polynaphthalenesulfonate, Lauryl Alcohol, Ethylhexylglycerin, 1,2-Hexanediol, Phenoxyethanol, Disodium EDTA

Otc - Purpose

This is a functional cosmetic reported as alleviating and improving hair loss symptoms

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Make foam enough, gently massage scalp and rinse thoroughly with water.

Warnings

If there are any abnormal symptoms or side effects such as red spots, swelling, or itching due to direct sunlight during or after using cosmetics. 2. Avoid using areas with wounds. 3. Precautions for storage and handling. 3.1) Keep out reach of children. 3.2) Keep it out of direct sunlight.

Dosage & Administration

For external use only

* Please review the disclaimer below.