NDC 50663-395 Zotos Professional Nutri For Women 2% Minoxidil Topical Solution
Minoxidil Solution Topical

Product Information

What is NDC 50663-395?

The NDC code 50663-395 is assigned by the FDA to the product Zotos Professional Nutri For Women 2% Minoxidil Topical Solution which is a human over the counter drug product labeled by Henkel Us Operations Corporation. The generic name of Zotos Professional Nutri For Women 2% Minoxidil Topical Solution is minoxidil. The product's dosage form is solution and is administered via topical form. The product is distributed in a single package with assigned NDC code 50663-395-00 1 bottle, dropper in 1 box / 60 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code50663-395
Proprietary Name 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.		Zotos Professional Nutri For Women 2% Minoxidil Topical Solution
Non-Proprietary Name 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.		Minoxidil
Product Type 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.		Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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.		Henkel Us Operations Corporation
Labeler Code50663
FDA Application Number 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.		ANDA078176
Marketing Category 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.		ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		03-06-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Zotos Professional Nutri For Women 2% Minoxidil Topical Solution?


Product Packages

NDC Code 50663-395-00

Package Description: 1 BOTTLE, DROPPER in 1 BOX / 60 mL in 1 BOTTLE, DROPPER

Product Details

What are Zotos Professional Nutri For Women 2% Minoxidil Topical Solution Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • MINOXIDIL 20 mg/mL - A potent direct-acting peripheral vasodilator (VASODILATOR AGENTS) that reduces peripheral resistance and produces a fall in BLOOD PRESSURE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p371)

Zotos Professional Nutri For Women 2% Minoxidil Topical Solution Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Zotos Professional Nutri For Women 2% Minoxidil Topical Solution Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Zotos Professional Nutri For Women 2% Minoxidil Topical Solution Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Drug Facts




Active Ingredient



Minoxidil 2% w/v


Purpose



Hair regrowth treatment


Use



to regrow hair on the scalp


Warnings



For external use only.

Flammable: Keep away from fire or flame


Do Not Use If:



• your amount of hair loss is different than that shown on the side of this carton, because this product may not work for you • you have no family history of hair loss • your hair loss is sudden and/or patchy • your hair loss is associated with childbirth • you do not know the reason for your hair loss • you are under 18 years of age. Do not use on babies and children • your scalp is red, inflamed, infected, irritated, or painful • you use other medicines on the scalp


Ask A Doctor Before Use If You Have



heart disease


When Using This Product



• do not apply on other parts of the body • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results • the amount of hair regrowth is different for each person. This product will not work for all women.


Stop Use And Ask A Doctor If



• chest pain, rapid heartbeat, faintness, or dizziness occurs
• sudden, unexplained weight gain occurs
• your hands or feet swell
• scalp irritation or redness occurs
• unwanted facial hair growth occurs
• you do not see hair regrowth in 4 months


May Be Harmful If Used When Pregnant Or Breast-Feeding.




Keep Out Of Reach Of Children.



If swallowed, get medical help, or contact a Poison Control Center right away.


Directions



• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area • using more or more often will not improve results • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again


Other Information



• see hair loss pictures on side of this carton • before use, read all information on carton and enclosed leaflet • keep the carton. It contains important information. • In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
• Store at controlled room temperature 20° to 25°C (68° to 77°F)


Inactive Ingredients



Alcohol, Propylene Glycol, Purified Water


Questions?



Call toll-free 1-800-242-9283 Visit Website at zotosprofessional.com


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