NDC 51672-2129 Minoxidil For Women

Minoxidil

NDC Product Code 51672-2129

NDC Code: 51672-2129

Proprietary Name: Minoxidil For Women 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

  • 51672 - Taro Pharmaceuticals U.s.a., Inc.
    • 51672-2129 - Minoxidil

NDC 51672-2129-4

Package Description: 1 CAN in 1 PACKAGE > 60 g in 1 CAN

NDC 51672-2129-8

Package Description: 2 CAN in 1 PACKAGE > 60 g in 1 CAN

NDC Product Information

Minoxidil For Women with NDC 51672-2129 is a a human over the counter drug product labeled by Taro Pharmaceuticals U.s.a., Inc.. The generic name of Minoxidil For Women is minoxidil. The product's dosage form is aerosol, foam and is administered via topical form.

Labeler Name: Taro Pharmaceuticals U.s.a., Inc.

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

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 For Women 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/g

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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ALCOHOL (UNII: 3K9958V90M)
  • ISOBUTANE (UNII: BXR49TP611)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • BUTANE (UNII: 6LV4FOR43R)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPANE (UNII: T75W9911L6)
  • WATER (UNII: 059QF0KO0R)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

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: Taro Pharmaceuticals U.s.a., Inc.
Labeler Code: 51672
FDA Application Number: ANDA209074 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: 04-22-2019 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.

Information for Patients

Minoxidil

Minoxidil is pronounced as (mi nox' i dill)

Why is minoxidil medication prescribed?
Minoxidil is used with other medications to treat high blood pressure. It is in a class of medications called vasodilators. It works by relaxing the blood vessels so that...
[Read More]
Minoxidil Topical

Minoxidil Topical is pronounced as (mi nox' i dill)
Why is minoxidil topical medication prescribed?
Minoxidil is used to stimulate hair growth and to slow balding. It is most effective for people under 40 years of age whose hair loss is recent. Minoxidil has no effect o...
[Read More]

* Please review the disclaimer below.

Minoxidil For Women Product Label Images

Minoxidil For Women 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

Other

Drug Facts

Distributed by:Taro Pharmaceuticals U.S.A., Inc.Hawthorne, NY 10532

Active Ingredient

Minoxidil 5% w/w (without propellant)

Purpose

Hair regrowth treatment for women

Use

To regrow hair on the top of the scalp (see pictures on side of this carton)

Warnings

For external use only.

Extremely Flammable

Avoid fire, flame, or smoking during and immediately following application.

Do Not Use If

  • Your degree of hair loss is different than that shown on side of this carton because this product may not work for youyou have no family history of hair lossyour hair loss is sudden and/or patchyyour hair loss is associated with childbirthyou 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

Otc - Ask Doctor

Ask a doctor before use if you have heart disease

When Using This Product

  • Do not use more than directeddo 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 3 months with once daily use. For some women, you may need to use this product once a day for at least 6 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 occurssudden, unexplained weight gain occursyour hands or feet swellscalp irritation or redness occursunwanted facial hair growth occursyou do not see hair regrowth in 6 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. (1-800-222-1222)

Directions

  • See enclosed leaflet for complete directions on how to useapply half a capful once daily directly to the scalp in the hair loss areamassage into scalp with fingers, then wash hands wellusing 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.store at controlled room temperature 20° to 25°C (68° to 77°F)contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Inactive Ingredients

Butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

  • Call 1-866-923-4914

* Please review the disclaimer below.

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