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

  • NDC Code(s): 83767-301-01, 83767-301-02, 83767-301-03
  • Packager: Guangzhou Ruijiu Electronic Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 25, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    5% Minoxidil Hair Regrowth Solution With Biotin

  • ACTIVE INGREDIENT

    Minoxidil 5%
    Biotin 0.2%

  • PURPOSE

    Hair Regrowth

  • INDICATIONS & USAGE

    Use to regrow hair of scalp and beard

  • 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 alarge amount of cool tap water.
    You need to use this product 1 times a day for at least 3 months beforeyou see results, The amount of hair regrowth is different for each person.

  • STOP USE

    Ifscalp irritation or redness occurs.
    lf you get unwanted facial hair growth.
    lf you do not see hair regrowth in 4 months.
    lf sudden, unexplained weight gain occurs.

  • KEEP OUT OF REACH OF CHILDREN

    lf swallowed, get medical help or contact a Poison Control Center
    (1-800-222-1222)right away.

  • DOSAGE & ADMINISTRATION

    Apply 1 ml of Minoxidil Serum directly onto the scalp in the hair loss area.
    Use fingertips to massage solution into skin/hair for 1 minutes thenwashhands thoroughly.
    Men: use twice daily.Women: use once daily on clean, dry hair for best results.

  • STORAGE AND HANDLING

    Before use, read all information on carton and enclosed leaflet Storeat controlled room temperature 10° to 25°C (50° to 77°F)
    Do not incinerate container. Do not expose to heat or store attemperature above 104°F(40°C).

  • INACTIVE INGREDIENT

    CASTOR OIL
    ALCOHOL
    GLYCERIN
    CETYL ALCOHOL
    LACTIC ACID
    WATER

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR REGROWTH SOLUTION WITH BIOTIN 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83767-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83767-301-011 in 1 PACKAGE07/26/2024
    160 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:83767-301-022 in 1 PACKAGE07/26/2024
    260 g in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:83767-301-033 in 1 PACKAGE07/26/2024
    360 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03207/26/2024
    Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ruijiu Electronic Technology Co., Ltd.631973699manufacture(83767-301)