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

  • NDC Code(s): 83988-004-01
  • Packager: Jinan Guyun Technology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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

  • SPL UNCLASSIFIED SECTION

    5% Minoxidil Hair Growth Foam with Biotin

  • ACTIVE INGREDIENT

    Minoxidil 5%
    Biotin 0.5%

  • PURPOSE

    Hair Regrowth Treatment

  • INDICATIONS & USAGE

    Use to regrow hair of the scalp

  • WARNINGS

    Flammable:keep away from fire or flame.

    Keep out of reach of children.

    For external use only

  • DO NOT USE

    Your hair loss is sudden and/or patchy.

    Your hair loss is associated with childbirth.

    You do not know the reason for your hair loss

    You are under 18 vears 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

    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 3 months with twice a day usage. For some men, you may need to use this productfor at least 6 months before you see results. The amount of hair regrowth is different for each person.

    Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water.

  • STOP USE

    Chest pain, rapid heartbeat, faintness, or dizziness occurs

    Sudden, unexplained weight gain occurs.

    If unwanted facial hair growth occurs.

    If you do not see hair regrowth in 6 months.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    1.Hold the botile upside down and gently press the valve to dispense foam onto your hand or a cold surface, approximately half a capful in size.

    2.Massage the foam into your scalp with your fingers, parting your hair into rows to ensure even application to areas of thinning hair. Finally,wash your hands thoroughly.
    3.Use Twice Daily and enjoy thicker, fuller hair growth in as little as 3 to 6 months.

  • STORAGE AND HANDLING

    Before use, read all information on the carton and the enclosed leaflet.Store at a controlled room temperature of 20°C to 25°C (68°F to 77°F)
    Do not incinerate the container. Do not expose it to heat or store it at temperatures above 40°C (104°F)

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN 
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83988-004
    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
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOBUTANE (UNII: BXR49TP611)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    BUTANE (UNII: 6LV4FOR43R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83988-004-015 in 1 PACKAGE12/16/2024
    160 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)12/16/2024
    Labeler - Jinan Guyun Technology Co., Ltd (544454964)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jinan Guyun Technology Co., Ltd544454964manufacture(83988-004)