NDC 72484-094 Minoxidil Extra Strength For Men

Minoxidil

NDC Product Code 72484-094

NDC 72484-094-03

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 60 mL in 1 BOTTLE, DROPPER

NDC Product Information

Minoxidil Extra Strength For Men with NDC 72484-094 is a a human over the counter drug product labeled by Roman Health Ventures Inc.. The generic name of Minoxidil Extra Strength For Men is minoxidil. The product's dosage form is solution and is administered via topical form.

Labeler Name: Roman Health Ventures Inc.

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.


Minoxidil Extra Strength For Men 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 50 mg/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • 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: Roman Health Ventures Inc.
Labeler Code: 72484
FDA Application Number: ANDA075518 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: 04-11-2019 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.

Minoxidil Extra Strength For Men Product Label Images

Minoxidil Extra Strength For Men 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

Minoxidil, USP 5% w/v

Purpose

Hair regrowth treatment for men

Use

To regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

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

Do Not Use If

  • 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. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.you 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 children.your scalp is red, inflamed, infected, irritated, or painfulyou 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 bodyavoid 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 textureit takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use 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.

Stop Use And Ask A Doctor If

  • Chest pain, rapid heartbeat, faintness, or dizziness occurssudden, unexplained weight gain occursyour hands or feet swellscalp irritation or redness occursunwanted facial hair growth occursyou do not see hair regrowth in 4 months

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 areausing more or more often will not improve resultscontinued 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 cartonbefore use, read all information on carton and enclosed leafletkeep 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 minoxidil topical solution 5% for menIn clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive Ingredients

Alcohol (30% v/v), propylene glycol (50% v/v), purified water

Questions?

1-888-828-2872 between 9 am and 5 pm ET, Monday–Friday.

* Please review the disclaimer below.

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