NDC 71761-260 Barbiux Balsamic Tonic 5%

Minoxidil

NDC Product Code 71761-260

NDC Code: 71761-260

Proprietary Name: Barbiux Balsamic Tonic 5% 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

  • 71761 - Incredible Products, S.a. De C.v.
    • 71761-260 - Barbiux Balsamic Tonic 5%

NDC 71761-260-60

Package Description: 60 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Barbiux Balsamic Tonic 5% with NDC 71761-260 is a a human over the counter drug product labeled by Incredible Products, S.a. De C.v.. The generic name of Barbiux Balsamic Tonic 5% is minoxidil. The product's dosage form is solution and is administered via topical form.

Labeler Name: Incredible Products, S.a. De C.v.

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.

Barbiux Balsamic Tonic 5% 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 .05 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.

  • RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
  • BERGAMOT ORANGE (UNII: IET5D90X0D)
  • AMINO ACIDS (UNII: 0O72R8RF8A)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Incredible Products, S.a. De C.v.
Labeler Code: 71761
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: 07-03-2019 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.

Barbiux Balsamic Tonic 5% 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 5% w/v

Purpose:

Hair regrowth treatment for men

Use:

Combat hair loss by reviving your hair follicles so you can safely and effectively experience hair regrowth.

Warnings:

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

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 texture
  • It 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

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

Inactive Ingredients:

Ricinus communis, Citrus bergamia, amino acids, mint extract, propylene glycol.

Questions?

  • Call toll-free 800-764-2463 or 215-273-8755 (collect)visit www.rogaine.com

* Please review the disclaimer below.

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