Label: 5% MINOXIDIL HAIR GROWTH FOAM- minoxidil aerosol, foam

  • NDC Code(s): 85304-019-01, 85304-019-02
  • Packager: Guangzhou Borderless Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 29, 2025

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

  • ACTIVE INGREDIENT

    Minoxidil 5%
    Biotin 0.5%

  • PURPOSE

    Hair regrowth treatment for men and women

  • INDICATIONS & USAGE

    Use to regrow hair of the scalp

  • WARNINGS


    Flammable: keep away from fire or flame.
    Keep out of reach of children.
    For extemal use only.

  • DO NOT USE


    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.

  • WHEN USING


    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 ime to regrow hair, results may occur at2 months with twice a day usage, for some people, you may need to use this product for at least 4 months before you see results.
    The amount of hair regrowth is diferent for each person. This product wil not work for all people.

  • STOP USE


    Chest pain,rapid heartbeat faintness, or dizziness occurs.
    Sudden,unexplained weight gain oceurs.
    Your hands or feet swell.
    Scalp irritation or redness occurs.
    Unwanted facial hair growth occurs.
    You do not see hair regrowth in 4 months.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if swalowed, get medical help or contact a Poison control Center (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION


    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 directions 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.

  • INACTIVE INGREDIENT

    cetyl alcohol
    citric acid
    glycerin
    isobutane
    lactic acid
    polysorbate 60
    purified water
    SD alcohol 40-B
    stearyl alcohol
    butane
    edetate disodium

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR GROWTH FOAM 
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85304-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID (UNII: 33X04XA5AT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    BUTANE (UNII: 6LV4FOR43R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ISOBUTANE (UNII: BXR49TP611)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85304-019-014 in 1 PACKAGE09/29/2025
    160 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:85304-019-028 in 1 PACKAGE09/29/2025
    260 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/29/2025
    Labeler - Guangzhou Borderless Technology Co., Ltd. (452282332)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Borderless Technology Co., Ltd.452282332manufacture(85304-019)