Label: HEAD AND SHOULDERS SCALP X MINOXIDIL HAIR REGROWTH TREATMENT FOR MEN- minoxidil aerosol, foam

  • NDC Code(s): 69423-587-01
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 27, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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.

    Do not use if

    • ​​​you are a woman
    • your 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 loss
    • your hair loss is sudden and/or patchy
    • you do not know the reason for your hair loss
    • you are under 18 years of age. Do not use on babies and children
    • your scalp is red, inflamed, infected, irritated or painful
    • you use other medicines on the scalp

    Ask a doctor before use if you have heart disease

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

    When using this product

    • do not apply on other parts of the body
    • avoid 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 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.

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

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

    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 area
    • massage into scalp with fingers, then wash hands well
    • see enclosed leaflet for complete directions on how to use
    • 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 information

    • hair growth has been shown in a clincial study of men (mostly white) aged 18-49 years who used it for 4 months
    • see hair loss pictures on side of this carton
    • before use, read all information on package and enclosed leaflet
    • keep the package. It contains important information
    • store 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

  • SPL UNCLASSIFIED SECTION

    DIST. BY PROCTER & GAMBLE

    CINCINNATI OH 45202.

  • PRINCIPAL DISPLAY PANEL - Carton

    Head & Shoulders

    SCALP X

    MINOXIDIL

    TOPICAL AEROSOL, 5% (FOAM)

    HAIR REGROWTH

    TREATMENT

    FOR MEN

    CLINICALLY PROVEN TO HELP REGROW HAIR

    Reactivates hair follicles to stimulate regrowth

    Once-a-day foam for women

    Six month supply

    Unscented

    3 CANS - 2.11 OZ (60 g) EACH

    CARTON

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS SCALP X MINOXIDIL HAIR REGROWTH TREATMENT FOR MEN 
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-587
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-587-013 in 1 CARTON11/01/2021
    160 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09134411/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)