Label: SOLUTION- minoxidil solution

  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 27, 2017

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

  • Active Ingredient

    Minoxidil 2% w/v..........................................................................................................Hair regrowth treatment

  • Use

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

  • WarningsFor external use only.

    Flammable: Keep away from fire or flame

  • Do not use if:

    • Your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
    • You have no family history of hair loss
    • Your hair loss is sudden and/or patchy
    • Your hair loss is associated with childbirth
    • 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. You may need to use this product 2 times a day 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 everyone
  • 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.


  • 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
    • In clinical studies of mostly white women aged 18-49 years wiht mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it for 8 months (7% had moderate regrowth, 33% had minimal regrowth)
    • Store at controlled room temperature 20​o​ to 25​o​C (68​o​ to 77​o​F). Keep tightly closed.
  • 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 you hair regrowth, or hair loss will begin again
  • Inactive Ingredients

    Alcohol, Propylene Glycol, Purified Water

  • Label

    image descriptionimage description

    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL0.02 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2173-021 in 1 PACKAGE08/08/2014
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    NameAddressID/FEIBusiness Operations
    Ei LLC105803274manufacture(0363-2173)
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135label(0363-2173)