Label: 5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN- minoxidil liquid

  • NDC Code(s): 83767-401-01, 83767-401-02
  • Packager: Guangzhou Ruijiu Electronic Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 19, 2024

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

  • SPL UNCLASSIFIED SECTION

    5% Minoxidil Hair Regrowth Serum With Biotin

  • ACTIVE INGREDIENT

    Minoxidil 5%
    Biotin 0.5%

  • PURPOSE

    Hair regrowth treatment

  • INDICATIONS & USAGE

    Use to regrow hair on the scalp and promote beard growth for men.

  • WARNINGS

    For extérnal use only.
    Keep out of reach of children.

  • DO NOT USE

    You have no family history of hair loss.
    Your halr 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 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

    Avoid contact with eyes.In case of accidental contact, rinse eyeswith a large amountof cool tap water.
    You need fo use this product once a day for best results.Theamount of hair regrowth varies for each person.

  • STOP USE

    lf chest pain, rapid heartbeat, faintness, or dizziness occurs.
    lf sudden,unexplained weight gain occurs.
    lf your hands or feet swell.
    if scalp irritation or redness occurs.
    lf you get unwanted facial hair growth occurs.
    lf you do not see hair regrowth in 4 months.

  • 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

    Apply3-6 drops Minoxidil Serum directly onto scalp on the hair loss area,(3-4 drops for women, 5-6 drops for men).
    Massage with your hands for 1 minute. After massaging, wash your hands thoroughly.
    Used once daily on clean dry hair for best results.

  • STORAGE AND HANDLING

    Before use, read all information on carton and enclosed leaflet.Store at controlled room temperature 10'C to 25°℃ (50°F to 77°F)Do not incinerate container. Do not expose to heat or store attemperature above 104°F(40°C)

  • INACTIVE INGREDIENT

    Alcohol
    Panthenol
    Glycerin
    Anhydrous citric acid
    Polysorbate 60
    Carbomer homopolymer
    Water

  • PRINCIPAL DISPLAY PANEL

    labellabel2

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83767-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.5 g  in 100 mL
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83767-401-011 in 1 PACKAGE08/20/2024
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:83767-401-022 in 1 PACKAGE08/20/2024
    2100 mL 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)08/20/2024
    Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ruijiu Electronic Technology Co., Ltd.631973699manufacture(83767-401)