• NDC Code(s): 69113-431-00
  • Packager: Scientific Hair Research, LLC
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 26, 2023

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

  • Drug Facts

  • Active Ingredient

    Minoxidil 5% w/v


    Hair regrowth treatment for men

  • Use

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

  • Warnings

    For external use only, For use by men only.

    Flammable:Keep away from fire or flame

    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, 5% minoxidil topical solution 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, 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 of 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 raech of children.

    If swallowed, get medical help, or contact a Poison Control Center right away.

  • Directions

    apply one mL with dropper 2 times a daydirectly onto the scalp in the hair loss area

    • 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

    • 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.

    • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men.

    • in clinical studies of mostly white men age 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

    store at controlled room temperature 20º to 25ºC (68º to 77ºF).

  • Inactive ingredients

    Alcohol, Propylene Glycol, Purified Water

  • Questions or comments?

    Call toll-free 1-800-BOSLEY1

    • Visit Website at
  • Package Labeling:

    Outer PackageInner Package

    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69113-431
    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
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69113-431-001 in 1 BOX11/03/2023
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Scientific Hair Research, LLC (961897647)