Label: GROWELL MENS HAIR REGROWTH TREATMENT 5 MINOXIDIL- minoxidil liquid

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

Drug Label Information

Updated May 16, 2024

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

  • Drug Facts

  • Active ingredient

    Minoxidil 5% w/v

    Purpose

    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, 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 the other parts of the body
    • avoid contact with the eyes. In caes 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
    • scalp irritation or redness occurs
    • sudden, unexplained weight gain occurs
    • unwanted facial hair growth occurs
    • your hands or feet swell
    • 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 Contrl Center right away.

  • Directions

    • apply one mL with dropper 2 times a daydirectly on to 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 wil begin again
  • Other information

    • see hair loss pictures on side of this carton
    • before use, reatd 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 more hair regrowth than 2% minoxidiltopical solution
    • store at controlled room temperature 20° to 25°C (68° to 77°F).
  • Inactive ingredients

    Alcohol, Propylene Glycol, Purified Water

  • Questions or comments?

    Call toll-free 1-(866)-982-7472

    Visit our website at www.GroWellHair.com

  • Package Labeling:

    Bottle0

  • INGREDIENTS AND APPEARANCE
    GROWELL MENS HAIR REGROWTH TREATMENT 5 MINOXIDIL 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84329-465
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84329-465-001 in 1 BOX03/04/2024
    160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623903/04/2024
    Labeler - APIRA SCIENCE, INC. (010514721)