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

  • NDC Code(s): 83988-002-01, 83988-002-02, 83988-002-03
  • Packager: Jinan Guyun Technology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 30, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    5% Minoxidil Hair Growth Foam with Biotin

  • 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 external 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 largeamounts 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 davusage, for some people, you may need to use this product for at least 4months before you see results.
    The amount of hair regrowth is different for each person. This product willnot work for all people.

  • STOP USE

    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,

  • 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

    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 hairloss will begin again.

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    ALCOHOL
    GLYCERIN
    CETYL ALCOHOL
    STEARYL ALCOHOL
    POLYSORBATE 80
    ANHYDROUS CITRIC ACID
    LACTIC ACID
    CASTOR OIL
    EDETATE DISODIUM
    ISOBUTANE
    BUTANE
    WATER

  • PRINCIPAL DISPLAY PANEL

    labellabel2label6

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN 
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83988-002
    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
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BUTANE (UNII: 6LV4FOR43R)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ALCOHOL (UNII: 3K9958V90M)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ISOBUTANE (UNII: BXR49TP611)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83988-002-012 in 1 PACKAGE10/31/2024
    160 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:83988-002-024 in 1 PACKAGE10/31/2024
    260 g in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:83988-002-036 in 1 PACKAGE10/31/2024
    360 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)10/31/2024
    Labeler - Jinan Guyun Technology Co., Ltd (544454964)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jinan Guyun Technology Co., Ltd544454964manufacture(83988-002)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!