Label: 5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN- minoxidil aerosol, foam

  • NDC Code(s): 84614-003-01, 84614-003-02
  • Packager: Shenzhen Ctrip Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 9, 2024

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  • SPL UNCLASSIFIED SECTION

    5% Minoxidil Hair Growth Foam with Biotin

  • ACTIVE INGREDIENT

    Minoxidil 5%
    Biotin 0.5%

  • PURPOSE

    Hair Regrowih Treaiment

  • INDICATIONS & USAGE

    Use to regrow hair of the scalp

  • WARNINGS

    Flammable:keep away from fire or flame.
    Keep out of reach of children.
    For exlernal use oniy

  • DO NOT USE

    Your hair loss is gudden andlor palchy.
    Your hair loss is associald with chidbinth.
    You do nol knaw the reason for your hair logs.
    You are under 18 years of age. Do not use on babies and children.
    Your gcalp is red, intamed, infecled, irritated, or painfu.
    You use other medicines on the scalp.

  • WHEN USING

    Awoid contact with the eyes. in case of accidenlal conlact, rinse eyes withlarge amcunts of cool tap waler.
    Some people have experienced changes in hair color andlor lexture.
    It takes time lo regrow hair, Resuts may ooour at 3 monihs with twice a dayusage. For some men, you may need to use this product for at least 6 monlhsbefore you see results. The amount of hair regrowih is diferent for eachpergon.
    Awoid contact with eyes. in case of aocidenlal contact, rinse eyes with alarge amcunt of cool tap waler.

  • STOP USE

    Chest pain, rapid hearibeat, aininegs, or dizziness oocurs.
    Sudden, unexplained weight gain oocurs.
    If umwaneed facil har growth occurs .
    lf you do nat see hair regrowth in 6 months.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.lf swalkwed, get medical help or contac a Poison Conlrol Cenler(1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    1.Shake the bollle, hold it upside down and genlly press the walve to dispensefoam onio your hand, approximalely the size of half a capful
    2.Massage the foam inio your gcalp with your fngers, paring your hair intorows to ensure even application to areas with thinning hair. Then, wash yourhands thoroughly.
    3.Use Twice Daily and enjoy thicker, fuler hair gronth in as lille as 3 to 6months.

  • STORAGE AND HANDLING

    Before use, read al informglion on carton and enclosed leale.Store at conlrolled room temperalure 20° lo 25°℃ (68° to 77°F)Do not incinerale container. Do not expose to heat or slore at lemperalureabove 104° F(40°C).

  • INACTIVE INGREDIENT

    ALCOHOL
    GLYCERIN
    CETYL ALCOHOL
    STEARYL ALCOHOL
    POLYSORBATE 80
    ANHYDROUS CITRIC ACID
    LACTIC ACID
    CASTOR OIL
    .ALPHA.-TOCOPHEROL
    EDETATE DISODIUM
    ISOBUTANE
    BUTANE
    WATER

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR GROWTH FOAM WITH BIOTIN 
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84614-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.5 g  in 100 g
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ISOBUTANE (UNII: BXR49TP611)  
    WATER (UNII: 059QF0KO0R)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84614-003-012 in 1 PACKAGE09/10/2024
    160 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:84614-003-023 in 1 PACKAGE09/10/2024
    260 g 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)09/10/2024
    Labeler - Shenzhen Ctrip Technology Co., Ltd. (403113060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Ctrip Technology Co., Ltd.403113060manufacture(84614-003)
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