NDC 49539-001 5% Minoxidil Topical Solution

Minoxidil

NDC Product Code 49539-001

NDC Code: 49539-001

Proprietary Name: 5% Minoxidil Topical Solution 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: Minoxidil 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

  • 49539 - Avacor Products, Llc
    • 49539-001 - 5% Minoxidil Topical Solution

NDC 49539-001-01

Package Description: 3 BOTTLE in 1 CARTON > 60 mL in 1 BOTTLE

NDC Product Information

5% Minoxidil Topical Solution with NDC 49539-001 is a a human over the counter drug product labeled by Avacor Products, Llc. The generic name of 5% Minoxidil Topical Solution is minoxidil. The product's dosage form is solution and is administered via topical form.

Labeler Name: Avacor Products, Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

5% Minoxidil Topical Solution 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.

  • MINOXIDIL 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.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Avacor Products, Llc
Labeler Code: 49539
FDA Application Number: ANDA076239 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 04-01-2019 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.

5% Minoxidil Topical Solution Product Label Images

5% Minoxidil Topical Solution 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

Minoxidil 5% w/v

Otc - Purpose

Hair regrowth treatment

Indications & Usage

Use to regrow hair on the scalp

Warnings

For external use only, For use by men only.Flammable: Keep away from fire or flame

Otc - Do Not Use

  • You are a womanyour amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp, 5% minoxidil topical solution is not intended for frontal baldness or receding hairlineyou have no family history of hair lossyour hair loss is sudden and/or patchyyou do not know the reason for your hair lossyou are under 18 years of age. Do not use on babies and childrenyour scalp is red, inflamed, irritated or painful • you use other medicines on the scalp

Otc - Ask Doctor

Ask a doctor before use if you have heart disease

Otc - When Using

• do not apply on other parts of the body • avoid contact with the eyes. In case of accidental contact, rinse eyes withlarge amounts of cool tap water • some people have experienced changes in hair color and/or texture• it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need touse this product 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 men.

Otc - Stop Use

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 of redness occurs• unwanted facial hair growth occurs• you do not see hair regrowth in 4 months

Otc - Pregnancy Or Breast Feeding

May be harmful if used when pregnant or breast-feeding.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Instructions For Use

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 Safety Information

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.• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men.• in clinical studies of mostly white men age 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution.• store at USP controlled room temperature 20º to 25ºC (68º to 77ºF).

Inactive Ingredient

Inactive Ingredients: Alcohol, Propylene Glycol, Purified Water

Dosage & Administration

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

* Please review the disclaimer below.

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