Label: 5% MINOXIDIL HAIR REGROWTH SPRAYS WITH BIOTIN- minoxidil spray

  • NDC Code(s): 83767-601-01, 83767-601-02, 83767-601-03
  • Packager: Guangzhou Ruijiu Electronic Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 3, 2024

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

  • SPL UNCLASSIFIED SECTION

    5% Minoxidil Hair Regrowth SPRAY With Biotin

  • ACTIVE INGREDIENT

    Minoxidil 5%
    Biotin 0.5%

  • PURPOSE

    Hair regrowth treatment

  • INDICATIONS & USAGE

    use to regrow hair of scalp and beard

  • WARNINGS

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

  • DO NOT USE

    You are a worran.
    You have no family history of hair loss.
    Your hair loss is sudden andjor 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 eyes, In case of accidental contact, rinse eyes with a larpe amount of cool tap water.
    The amount of hair regrowth is different for each person.This product wilt hot work for all men.

  • STOP USE

    If scalp irritation or redness occurs.
    if you get unwanted facial hair growth.
    if you do not see hair regrowith in 4 months.
    if sudden, unexplained weight gain occurs.
    if you have chest pain, rapid heartbeat, faintness, or dizziness occurs.
    if your hands or feet swell.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Apply 3-4 pumps of Extra Strength 5% Minoxidil Spray directly onto scalp on the hair loss area.
    Use fingertips to massage the spray into skin/hair for 1 minute, then wash hands thoroughly.
    Used twice daily on clean ,dry hair for best results.

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    Castor oil
    Alcohol
    Glycerin
    Butylene glycol
    Panthenol
    Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR REGROWTH SPRAYS WITH BIOTIN 
    minoxidil spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83767-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.5 g  in 100 mL
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83767-601-011 in 1 PACKAGE09/03/2024
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:83767-601-022 in 1 PACKAGE09/03/2024
    260 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:83767-601-033 in 1 PACKAGE09/03/2024
    360 mL 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)09/03/2024
    Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ruijiu Electronic Technology Co., Ltd.631973699manufacture(83767-601)