NDC 69423-587 Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men

Minoxidil

NDC Product Code 69423-587

NDC CODE: 69423-587

Proprietary Name: Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Minoxidil is used with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Minoxidil works by relaxing blood vessels so blood can flow more easily.

NDC Code Structure

  • 69423 - The Procter & Gamble Manufacturing Company
    • 69423-587 - Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men

NDC 69423-587-01

Package Description: 3 CAN in 1 CARTON > 60 g in 1 CAN

NDC Product Information

Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men with NDC 69423-587 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men is minoxidil. The product's dosage form is aerosol, foam and is administered via topical form.

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.

Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment 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.


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)
  • BUTANE (UNII: 6LV4FOR43R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ISOBUTANE (UNII: BXR49TP611)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPANE (UNII: T75W9911L6)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • 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: The Procter & Gamble Manufacturing Company
Labeler Code: 69423
FDA Application Number: ANDA091344 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: 11-01-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men Product Label Images

Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment 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

Other

Drug Facts

DIST. BY PROCTER & GAMBLECINCINNATI OH 45202.

Active Ingredients

Minoxidil 5% w/w (without propellant)

Purpose

Hair regrowth treatment for men

Use

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

Warnings

For external use only. For use by men only.Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

Otc - Do Not Use

  • Do not use if​​​you are a womanyour amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Aerosol, 5% (Foam) 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 childrenyour 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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking any other drugs

Otc - When Using

  • 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 useage. 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.

Otc - Stop Use

  • Stop use and ask a doctor ifchest 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

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

  • Apply half a capful 2 times a day to the scalp in the hair loss areamassage into scalp with fingers, then wash hands wellsee enclosed leaflet for complete directions on how to useusing 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

  • Hair growth has been shown in a clincial study of men (mostly white) aged 18-49 years who used it for 4 monthssee hair loss pictures on side of this cartonbefore use, read all information on package and enclosed leafletkeep the package. It contains important informationstore at 20-25° C (68-77° F)contents under presure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120° F (49° C)

Inactive Ingredients

Butane, butylated hydroxytoluene, cetyl alcohol, citric acid, dehydrated alcohol. isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

1-800-723-9569

* Please review the disclaimer below.