Label: PROFOLIX MINOXIDIL HAIR GROWTH SERUM liquid

  • NDC Code(s): 81653-009-01, 81653-009-02
  • 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 November 28, 2023

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

  • Active Ingredient

    Minoxidil 5% w/v (without propellant)

  • Purpose

    Hair Regrowth Treatment For Scalp and beard Only

  • Use

    To Regrow hair, For Scalp and beard Only

  • Warnings

    Keep away from kids.
    for external use only
    Flammable: Keep away from fire or flame
    If swallowed, seek medical help, or contact poison control.
    Store at controlled room temperature 20 to 25 ° C (68 to 77 ° F)
    Do not expose to heat or store at temperature above 49 ° C (120 ° F)
    Avoid fire, flame, or smoking during and immediately following application.

  • Do not use

    your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
    No family history of hair loss
    Sudden or patchy hair loss
    Unknown cause of hair loss
    Under 18 years old (Avoid use on babies and children).
    Red, inflamed, infected, irritated, or painful scalp.
    Use of other scalp medications
    May be harmful if used when pregnant or breast - feeding.

  • When Using

    Apply only on the scalp or beard
    Avoid contact with eyes (Rinse with cool water if contact occurs)

  • Stop Use

    Experience chest pain, rapid heartbeat, faintness, or dizziness
    Sudden, unexplained weight gain
    Swelling of hands or feet
    Scalp irritation or redness
    Unwanted facial hair growth
    No hair regrowth after 4 months

  • Ask Doctor

    If have Allergy, plz check with doctor

  • Keep Oot Of Reach Of Children

    Keep Oot Of Reach Of Children

  • Directions

    Roll the roller gently across the treated scalp area, 5-10 times, in horizontal, vertical, and diagonal motions.
    Apply 2-3 drops to the treated scalp area.
    Massage in with fingers and wash hands thoroughly.
    More serum or frequent use won't enhance results.
    Consistent use is key for hair regrowth. Stopping may lead to hair loss.
    Results may take at least 4 months with daily use (recommended: men: Once daily, Women: Twice daily)
    Effectiveness varies from person to person.

  • IMPORTANT

    The hair growth cycle is around 6 months. Consistent use is crucial for effectiveness, and visible results may appear after 3-4 months. Keep up the treatment post-initial improvements to sustain progress; discontinuation may lead to withdrawal.

  • 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.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PROFOLIX MINOXIDIL HAIR GROWTH SERUM 
    profolix minoxidil hair growth serum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81653-009
    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
    CARTHAMUS TINCTORIUS WHOLE (UNII: 5EMV416J82)  
    LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)  
    GLYCYRRHIZA URALENSIS WHOLE (UNII: 8XW1DS8UIR)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    BIOTIN (UNII: 6SO6U10H04)  
    DICTAMNUS DASYCARPUS ROOT (UNII: 6153LEN214)  
    ALCOHOL (UNII: 3K9958V90M)  
    ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)  
    HOODIA GORDONII SAP (UNII: K7QNF2DJR8)  
    WATER (UNII: 059QF0KO0R)  
    GINGER (UNII: C5529G5JPQ)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    REYNOUTRIA MULTIFLORA STEM (UNII: 9V97G011CE)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    LIGUSTRUM LUCIDUM FRUIT (UNII: M9G2U96DUT)  
    COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81653-009-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product11/12/2023
    2NDC:81653-009-02180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535711/12/2023
    Labeler - Guangzhou Jianyuan Biological Technology.Co.,Ltd (548120189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Jianyuan Biological Technology.Co.,Ltd548120189manufacture(81653-009)