Label: MINOXIDIL solution

  • NDC Code(s): 0363-9971-02, 0363-9971-06
  • Packager: Walgreens
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 11, 2023

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

  • Drug Facts

  • Active ingredient

    Minoxidil, USP 5% w/v

  • 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: 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. Minoxidil topical solution 5% 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 one mL with dropper 2 times a day directly 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 minoxidil topical solution 5% for men
    • In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
    • store at controlled room temperature 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    alcohol (30% v/v), propylene glycol (50% v/v), purified water

  • Questions?

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

  • Principal display panel

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

    Minoxidil Topical Solution, USP 5%,


    For Men  Topical Solution

    Unscented  Extra Strength

    • Reactivates hair follicles to stimulate regrowth
    • Clinically proven to help regrow hair
    • For best results, apply directly to scalp twice daily


    ††This product is not affiliated with, manufactured by, or produced by the makers or owners of Rogaine®.


    DEERFIELD, IL 60015

  • Package label

    Minoxidil, USP 5% w/v

    WALGREENS Hair Regrowth Treatment

    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9971
    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:0363-9971-021 in 1 CARTON10/14/2022
    160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0363-9971-063 in 1 BOTTLE10/14/2022
    260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Walgreens (008965063)