Label: FINALLY HAIR MINOXIDIL 5% HAIR GROWTH FOAM (hair growth foam- serum liquid

  • NDC Code(s): 81653-011-01
  • 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 9, 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. Avoid getting product in your eyes or mouth. If contact occurs, rinse with water and consultant a doctor. Keep out of reach of children. Do not apply on broken or irritated skin.

  • Do not use

    ■ you are a pregnant woman
    ■ 5% minoxidil topical solution 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

    heart disease

  • Keep Oot Of Reach Of Children

    Yes, Keep Oot Of Reach Of Children

  • Directions

    ■ apply right amount directly to the scalp in the hair loss area.
    ■ massage into scalp with fingers, then wash hands well.
    ■ 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

    Aqua, Biotin, EDTA ,Methylparaben, Allantoin, Adenosine, Niacinamide, Water Soluble Azone, Phenoxyethanol, Propylene Glycol, Collagen

  • Questions

    Info@finallyhair.com

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    FINALLY HAIR MINOXIDIL 5% HAIR GROWTH FOAM 
    hair growth foam (serum) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81653-011
    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
    NIACINAMIDE (UNII: 25X51I8RD4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TETRAMETHYLCHROMANOL GLUCOSIDE (UNII: 7YWI9T8733)  
    ADENOSINE (UNII: K72T3FS567)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81653-011-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535712/08/2023
    Labeler - Guangzhou Jianyuan Biological Technology Co.,Ltd (548120189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Jianyuan Biological Technology Co.,Ltd548120189manufacture(81653-011)