Label: HIMS- minoxidil 5% liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 30, 2017

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

  • ACTIVE INGREDIENT

    Minoxidil 5% w/v

  • PURPOSE

    Hair regrowth treatment for men

  • INDICATIONS & USAGE

    to regrow hair on 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. 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 right away.

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    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 SAFETY 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 aged 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 INGREDIENT

    alcohol, propylene glycol, purified water

  • QUESTIONS

    Questions or Comments: Call toll-free 1 (800) 368-0038 or Visit Website at www.forhims.com

  • PRINCIPAL DISPLAY PANEL

    Box

  • INGREDIENTS AND APPEARANCE
    HIMS 
    minoxidil 5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71730-042
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71730-042-081 in 1 BOX11/18/2017
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07551811/01/2017
    Labeler - Clubroom, Inc. (080696472)