Label: MINOXIDIL aerosol, foam

  • NDC Code(s): 59726-125-60, 59726-125-70
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 18, 2023

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  • Drug Facts

  • Active ingredient

    Minoxidil, USP 5% w/v (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 carton)

  • Warnings

    For external use only. For use by men only.
    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 the 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

    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 (1-800-222-1222) right away.

  • 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 clinical study of men (mostly white) aged 18-49 years who used it for 4 month
    • 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 120º F (49º C).
  • Inactive ingredients

    butane, butylated hydroxytoluene, cetyl alcohol, citric acid glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40-B, stearyl alcohol

  • Questions?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal display panel

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

    men's hair regrowth treatment

    Minoxidil Topical aerosol, 5%

    hair regrowth treatment

    • Clinically proven to help regrow hair
    • reactivates hair follicles to stimulate regrowth
    • unscented

    easy-to-use foam

    NOT FOR USE BY WOMEN

    THREE MONTH SUPPLY

    THREE 60 G (2.11 OZ) CANS

    mL (FL OZ) BOTTLE

    *This product is not manufactured by, or distributed by Johnson & Johnson Comsumer Inc., distributor of Men's Rogaine®

    Distributed by: PL Developments

    200 Hicks Street, Westbury, NY 11590

  • Package label

    Minoxidil 5% w/w (without propellant)

    WELLNESS BASICS Men's Hair regrowth Treatment

  • INGREDIENTS AND APPEARANCE
    MINOXIDIL 
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOBUTANE (UNII: BXR49TP611)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPANE (UNII: T75W9911L6)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59726-125-601 in 1 PACKAGE10/01/2023
    160 mL in 1 CAN; Type 0: Not a Combination Product
    2NDC:59726-125-703 in 1 PACKAGE10/01/2023
    260 mL in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20809210/01/2023
    Labeler - P & L Development, LLC (800014821)
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