Label: MINOXIDIL (FOR MEN)- minoxidil aerosol, foam

  • NDC Code(s): 0363-9090-01, 0363-9090-03
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 10, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    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 pictures 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. 5% minoxidil topical 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

    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 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 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 clinical 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 carton and enclosed leaflet
    • keep 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
  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 60 g Can Carton

    NDC 0363-9090-01

    Walgreens

    Compare to the active
    ingredient in Men's Rogaine®††

    MINOXIDIL TOPICAL
    AEROSOL, 5% (FOR MEN)

    Hair
    Regrowth
    Treatment

    For Men

    Easy-to-Use Foam

    Unscented

    • Reactivates hair follicles
      to stimulate regrowth
    • Clinically proven to help
      regrow hair
    • #1 dermatologist
      recommended
      active ingredient*

    1
    CAN

    ONE-MONTH
    SUPPLY
    EASY-TO-USE
    FOAM

    2.11 OZ (60 g)

    NOT FOR USE BY WOMEN

    PRINCIPAL DISPLAY PANEL - 60 g Can Carton
  • INGREDIENTS AND APPEARANCE
    MINOXIDIL   (FOR MEN)
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1) Minoxidil50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    butane (UNII: 6LV4FOR43R)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cetyl alcohol (UNII: 936JST6JCN)  
    isobutane (UNII: BXR49TP611)  
    lactic acid, unspecified form (UNII: 33X04XA5AT)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    propane (UNII: T75W9911L6)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (white to off-white foam) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9090-011 in 1 CARTON08/19/2022
    160 g in 1 CAN; Type 0: Not a Combination Product
    2NDC:0363-9090-033 in 1 CARTON08/19/2022
    260 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20907408/19/2022
    Labeler - Walgreen Company (008965063)
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