Label: FINALLY HAIR MINOXIDIL 5% HAIR GROWTH SERUM- minoxidil 5% hair growth serum liquid

  • NDC Code(s): 81653-012-01
  • Packager: Guangzhou Jianyuan Biological Technology Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 19, 2023

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

  • Active Ingredient

    Minoxidil 5% w/ v.

  • Purpose

    Hair regrowth treatment for people

  • Use

    to regrow hair on the top of the scalp

  • Warnings

    For external use only.
    Flammable: Keep away from fire or flame

  • Do not use

    ■your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Hair Regrowth Treatment is not intended for frontal baldness or receding hairline.
    ■ you have no family history of hair loss
    ■ 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 time to regrow hair. Results may occur at 2 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 different for each person. This product will not 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.

  • Ask Doctor

    If have heart disease.

  • Keep Oot Of Reach Of Children

    Yes, Keep Oot Of Reach Of Children

  • Directions

    ■ apply 1 ml twice a day directly onto the scalp in the hair loss area
    ■ 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
    For best results: Keep using (Men use twice a daily. Women use once a day).

  • Other information

    ■ see hair loss pictures on side of this carton
    ■ before use, read all information on carton
    ■ keep the carton. It contains important information.
    ■ hair regrowth has not been shown to last longer than 48 weeks in large clinical
    trials with continuous treatment with Hair Regrowth Treatment for men and women
    ■ In clinical studies with mostly white men and women aged 18-49 years with
    moderate degrees of hair loss, Hair Regrowth Treatment for people provided
    more hair regrowth than minoxidil topical solution 2%
    ■ store at 20° to 25°C (68° to 77°F). Keep tightly closed.

  • Inactive ingredients

    Water, Alcohol, Ginseng Extract, Ginger Extract, Carthamus Tinctorius L. Extract,
    Cortex Dictamni, Fructus Ligustri Lucidi Extract, Ligusticum Chuanxiong Hort
    Extract, Glycyrrhiza Uralensis Fisch Extract, Arctium Lappa L., Angelica Sinensis,
    Cacumen Platycladi Orientalis P.E., Polygonum Multiflorum Thunb, Capsaicin,
    Vitamin H (Biotin), Collagen.

  • Questions

    Info@finallyhair.com

  • PRINCIPAL DISPLAY PANEL

    0102

  • INGREDIENTS AND APPEARANCE
    FINALLY HAIR MINOXIDIL 5% HAIR GROWTH SERUM 
    minoxidil 5% hair growth serum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81653-012
    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
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    BOK-CHOY (UNII: EKJ8Z7DEWI)  
    ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)  
    REYNOUTRIA MULTIFLORA ROOT OIL (UNII: 1HIE915O2J)  
    CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)  
    RUBUS CHINGII WHOLE (UNII: A32A8VI76N)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    GINGER (UNII: C5529G5JPQ)  
    DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    COLLAGEN ALPHA-1(II) CHAIN (UNII: 86V2W84PW4)  
    BIOTIN (UNII: 6SO6U10H04)  
    LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
    GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81653-012-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product12/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535712/18/2023
    Labeler - Guangzhou Jianyuan Biological Technology Co.,Ltd (548120189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Jianyuan Biological Technology Co.,Ltd548120189manufacture(81653-012)