Label: 5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution

  • NDC Code(s): 85174-001-02, 85174-001-03, 85174-001-04
  • Packager: Nanhong (Zhuhai) Biotechnology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2025

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

  • SPL UNCLASSIFIED SECTION

    5% MINOXIDIL TOPICAL SOLUTION

  • ACTIVE INGREDIENT

    MINOXIDIL 5%

  • PURPOSE

    Hair regrowth treatment for men

  • INDICATIONS & USAGE

    to regrow hair on the top of the scalp (vertex onlysee pictures on side of carton)

  • WARNINGS

    For external use only. For use by men only.

    Flammable: Keep away from fire or flame

  • DO NOT USE

    you are a woman
    your amount of hair loss is different than that shown onthe side of this carton, or your hair loss is on the front ofthe scalp.5% minoxidil topical solution is not intended forfrontal baldness or receding hairline.

    your hair loss is sudden and/or patchy

    you do not know the reason for your hair loss

    you are under 18 years of age. Do not use on babiesand 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 the eyes. In case of accidental contactrinse eyes with large amounts of cool tap water.

    some people have experienced changes in hair color and/or texture

    it takes time to regrow hair. Results may occur at 2months with twice a day usage. For some men, you mayneed to use this product for at least 4 months before yousee results.

    the amount of hair regrowth is different for each person.This product will not work for all men.

  • STOP USE

    chest pain, rapid hearbeat, faintness, or dizziness occurs

    sudden, unexplained weight gain occurs

    your hands or feet swell

    scalp irritation or redness occurs

    unwanted facial hair growth occursyou do not see hair regrowth in 4 months

  • KEEP OUT OF REACH OF CHILDREN

    May be harmful if used when pregnant or breast-feeding.Keep out of reach of children. lf swallowedget medical help or contact a Poison Control Centerright away.

  • DOSAGE & ADMINISTRATION

    apply one mL with dropper 2 times a day directly ontothe scalp in the hair loss area

    using more or more often will not improve results

    continued use is necessary to increase and keep yourhair regrowth,or hair loss will begin again

  • STORAGE AND HANDLING

    see hair loss pictures on side of this carton

    before use, read all information on carton

    keep the carton. lt contains important information.

    5% minoxidil topical solution for men provided more hairregrowth than 2% minoxidil topical solution

    store at controlled room temperature 20° to 25°C(68° to 77°F)

  • INACTIVE INGREDIENT

    ALCOHOL
    GLYCERIN
    PROPYLENE GLYCOL
    PURIFIED WATER

  • PRINCIPAL DISPLAY PANEL

    label1

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL TOPICAL SOLUTION 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85174-001
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85174-001-022 in 1 PACKAGE01/16/2025
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:85174-001-033 in 1 PACKAGE01/16/2025
    260 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:85174-001-044 in 1 PACKAGE01/16/2025
    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)01/16/2025
    Labeler - Nanhong (Zhuhai) Biotechnology Co., Ltd. (569163067)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanhong (Zhuhai) Biotechnology Co., Ltd.569163067manufacture(85174-001)