Label: 5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution

  • NDC Code(s): 82429-200-60
  • Packager: Gabar Health Sciences Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 22, 2022

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

  • ACTIVE INGREDIENT

    ​Drug Facts

    ​Active Ingredient

    Minoxidil 5% w/w (without propellant)

  • ​Purpose

    Hair regrowth treatment for men

  • ​Use

    To regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

  • ​Warnings

    For external use only.

    For use by men only.

    ​Extremely Flammable:​ Avoid fire, flame, or smoking during and immediately following application.

  • ​Do not use if

    • you are a woman
    • your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp 5% minoxidil topical foam is not intended for frontal baldmess 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 DOCTOR

    ​Ask a doctor before use if you have heart disease

  • WHEN USING

    ​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

    ​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
  • PREGNANCY OR BREAST FEEDING

    ​May be harmful if used when pregnant or breast feeding.

  • 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. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    ​Directions

    • ​apply half a capful 2 times a day to the scalp in the hair loss area
    • massage into scalp with fingers, then wash hands well
    • see enclosed leaflet for complete directons on how to use
    • 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

    ​Other information

    • hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
    • see hair loss picture on side of this carton
    • before use, read all information on carton and enclosed leaflet
    • keep the carton. It contains important information.
    • store at controlled room temperature 20º to 25ºC (68º to 77ºF)
    • contents under pressure. Do not puncture or incinerate container.
    • do not expose to heat or store at temperature above 120ºF (49ºC).
  • INACTIVE INGREDIENT

    ​Inactive ingredients

    ​butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

  • QUESTIONS

    ​Questions?

    • ​Call ​1-470-737-9424

    Manufactured and distributed by:

    Gabar Health Sciences Corp., Atlanta, GA 30385

  • ​PRINCIPAL DISPLAY PANEL

    ​Minoxidil Topical Aerosol, 5% (For Men)

    HAIR REGROWTH TREATMENT

    ​Reactivates hair follicles to stimulate regrowth

    Clinically proven to help regrow hair

    #1 Dermatologist Recommended Active Ingredient

    Easy-to-use-foam unscented

    3 MONTH SUPPLY

    3 - 60 g (2.11 OZ) CANS

    ​NOT FOR USE BY WOMEN

    Minoxidil Men Carton Label

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL TOPICAL SOLUTION 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82429-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTANE (UNII: BXR49TP611)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    BUTANE (UNII: 6LV4FOR43R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPANE (UNII: T75W9911L6)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    Colorwhite (white to off-white foam) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82429-200-6060 mL in 1 PACKAGE; Type 0: Not a Combination Product10/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/10/2022
    Labeler - Gabar Health Sciences Corp. (118401847)
    Registrant - Gabar Health Sciences Corp. (118401847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gabar Health Sciences Corp.118401847manufacture(82429-200)