NDC 73199-0001 Botaneth Pronoxin Hair Regainer

Zinc Pyrithione, Salicylic Acid

NDC Product Code 73199-0001

NDC Code: 73199-0001

Proprietary Name: Botaneth Pronoxin Hair Regainer 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: Zinc Pyrithione, Salicylic Acid 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.

NDC Code Structure

  • 73199 - Ouibon Global
    • 73199-0001 - Botaneth Pronoxin Hair Regainer

NDC 73199-0001-1

Package Description: 200 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Botaneth Pronoxin Hair Regainer with NDC 73199-0001 is a a human over the counter drug product labeled by Ouibon Global. The generic name of Botaneth Pronoxin Hair Regainer is zinc pyrithione, salicylic acid. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Ouibon Global

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.

Botaneth Pronoxin Hair Regainer 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 .2 g/100mL
  • PYRITHIONE ZINC .3 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.

  • 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: Ouibon Global
Labeler Code: 73199
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: 07-13-2019 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: 12-31-2020 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.

Botaneth Pronoxin Hair Regainer Product Label Images

Botaneth Pronoxin Hair Regainer 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, salicylic acid

Inactive Ingredient

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide MIPA, Isopropanolamine, Zinc Pyrithione, Sodium Polynaphthalenesulfonate, Panthenol, Pantolactone, Menthol, Isopulegol, Polyquaternium-10, Pinus Sylvestris Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Butylene Glycol, Eucalyptus Globulus Leaf Oil, Mentha Arvensis Leaf Oil, Amyris Balsamifera Bark Oil, Eucalyptus Globulus Leaf Oil, Litsea Cubeba Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Salicylic Acid, Chlorphenesin, Citric Acid, Disodium EDTA, Artemisia Vulgaris Extract, Curcuma Longa (Turmeric) Root Extract, Angelica Gigas Root Extract, Astragalus Membranaceus Root Extract, Acorus Gramineus Root/Stem Extract, Ginkgo Biloba Leaf Extract, Morus Bombycis Leaf Extract, Panax Ginseng Root Extract, 1,2-Hexanediol, Glycerin, Copper Tripeptide-1, Rehmannia Glutinosa Root Extract, Cornus Officinalis Fruit Extract, Dioscorea Japonica Root Extract, Alisma Orientale Tuber Extract, Poria Cocos Sclerotium Extract, Paeonia Suffruticosa Root Extract, Ethylhexylglycerin

Otc - Purpose

Protect scalp, hair loss prevention

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

1. APPLY TO WET HAIR WITH WARM WATER AND MASSAGE SCALP GENTLY.2. WAIT 3 MINUTES THEN RINSE OFF (3. USE ACTIVATOR AFTER DRYING HAIR)

Warnings

1. In case of using cosmetics or after use, please consult a specialist if there is any abnormal symptom or side effect such as red spot, swelling or itching in direct sunlight.

2. Do not use on wounded areas.

3. In case of contact with eyes, wash immediately.

4. Care should be taken not to rinse with water after use, as it may cause hair loss or discoloration.

Dosage & Administration

For topical use only

* Please review the disclaimer below.

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