Label: 5% MINOXIDIL HAIR GROWTH OIL- 5% minoxidil hair growth kit liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 2, 2023

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

  • Active Ingredient

    Minoxidil 5% w/w

  • Purpose

    Hair regrowth treatment

  • Use

    to regrow hair on the scalp

  • Warnings

    For external use only.

  • Do not use

    You have no family history of hair loss. 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 it on babies and children.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 eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water. It takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results, The amount of hair regrowth is different for each person.The product will not work for everyone.

  • Stop Use

    If scalp irritation or redness occurs. If you get unwanted facial hair growth. If you do not see hair regrowth in 4 months.If sudden, unexplained weight gain occurs.

  • Ask Doctor

    If you have chest pain, rapid heart beat, faintness,
    or dizziness occurs.

  • Keep Oot Of Reach Of Children

    If swallowed, get medical help or contact
    a poison control center right away.

  • Directions

    . Apply 2-3 drops of serum directly to the
    scalp in the area to be treated.
    . Massage into the scalp with your fingers
    then wash hands thoroughly.
    - Using more hair regrowth serum or
    using the serum more often will not
    improve your results.
    . Continued use is necessary to increase
    and then maintain your hair regrowth.
    . Discontinuing use may result in hair loss.

  • Other information

    Before use, read all information on the carton.
    Keep the carton. It contains important
    information.
    Store at controlled room temperature 20
    to 25℃ (68 to 77°F)
    Contents under pressure. Do not
    puncture or incinerate the container. Do
    not expose to heat or store at
    temperature above 120°F(49℃)

  • Inactive ingredients

    Inactive ingredients
    water, biotin, dimethyl isosorbide,
    acetic acid, panthenol, propylene glycol,
    niacinamide, polysorbate 20

  • PRINCIPAL DISPLAY PANEL

    01

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR GROWTH OIL 
    5% minoxidil hair growth kit liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83462-008
    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
    BIOTIN (UNII: 6SO6U10H04)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83462-008-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535711/02/2023
    Labeler - Eubizrival LLC (036572203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Hanhai Trading Co., Ltd419707381label(83462-008) , manufacture(83462-008)