Label: DAW MINOXIDIL TOPICAL SOLUTION MENS HAIR REGROWTH TREATMENT 5- minoxidil liquid

  • NDC Code(s): 82372-482-00
  • Packager: Good Manager Holdings Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 1, 2024

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

  • Drug Facts

  • Active ingredient

    Minoxidil 5%

    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 other part of the body
    • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amount of cool tap water
    • some people have experienced changes in hair colour 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 and pets.

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

  • Directions

    • apply one mL with dropper 2 times a days 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 tratment 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
  • Inactive ingredients:

    Alcohol, Propylene Glycol, Purified Water

  • Questions or comments?

    Visit Website at davvhealth.com

  • Package Labelling:

    Label

  • INGREDIENTS AND APPEARANCE
    DAW MINOXIDIL TOPICAL SOLUTION MENS HAIR REGROWTH TREATMENT 5 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82372-482
    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:82372-482-001 in 1 BOX05/06/2024
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623905/06/2024
    Labeler - Good Manager Holdings Inc (118382673)