Label: 5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN- minoxidil solution

  • NDC Code(s): 84614-001-01
  • Packager: Shenzhen Ctrip Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 2, 2024

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  • SPL UNCLASSIFIED SECTION

    5% MINOXIDIL HAIR REGROWTH SERUM With Biotin

  • ACTIVE INGREDIENT

    Minoxidil 5%
    Biotin 0.2%

  • PURPOSE

    Hair Regrowth

  • INDICATIONS & USAGE

    Use to regrow hair of the scalp and beard growth for men

  • WARNINGS

    For external use only.
    Keep out of reach of children.

  • DO NOT USE

    You have no family history of hair loss.Your hair loss is sudden and/or patchy.
    Your hair loss is associated with childbirth.
    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

    Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water.

  • STOP USE

    Chest pain, rapid heartbeat, faintness, or dizziness occurs.
    Sudden, unexplained weight gain occurs.
    Scalp irritation or redness occurs.
    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away.

  • DOSAGE & ADMINISTRATION

    Apply 3-6 drops Minoxidil Serum directly onto scalp on the hair loss area
    Use fingertips to massage solution into skin/hair for 1 minutes then washhands thoroughly.
    Used once daily on clean dry hair for best results

  • STORAGE AND HANDLING

    Before use, read all information on carton and enclosed leafletStore at controlled room temperature 10° to 30°C (50° to 80°F)Do not incinerate container. Do not expose toheat or store at temperature above 104°F(40°C)

  • INACTIVE INGREDIENT

    Butylene Glycol
    Glycerin
    Alcohol
    Panthenol
    Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR REGROWTH SERUM WITH BIOTIN 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84614-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84614-001-012 in 1 PACKAGE08/02/2024
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03208/02/2024
    Labeler - Shenzhen Ctrip Technology Co., Ltd. (403113060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Ctrip Technology Co., Ltd.403113060manufacture(84614-001)
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