Label: 5% MINOXIDIL TOPICAL SERUM- hair essential oil liquid

  • NDC Code(s): 83872-011-01
  • Packager: Shenzhen Xiaomai Manufacturing Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 28, 2024

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

  • Active Ingredient

    Minoxidil 5%

  • Purpose

    Hair Regrowth Treatment

  • Use

    Use to regrow hair on the top of the scalp

  • Wamings

    -For external use only
    -Keep away from fire and flame

  • Do not use

    -You have no family history of hair loss,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 it on bables and children your scalp is red.inflamed,infected,imitated,or painful.
    -You use other medicines on the scalp
    -Ask a Doctor before use of you have Heart disease.

  • When Using

    Do not apply to other parts of the body.void contact with eyes.In case of accidental contact,rinse eyes with a large amount of cool tap water.
    It takes time to regrow hair.You may need to use this product 2 times a day for a least 4 months before you see results,The amount of hair regrowth is different for each person.

  • Stop Use

    chest pain, rapid heart beat.faintness, or dizziness occurs sudden, unexplained weight gain occurs.
    your hands or feet swell scalp imitation or redness occurs
    May be harmful if used when pregnant or breast-feeding
    Keep Out Of Reach Of Chlidren:
    if swallowed,get medical help or
    contact a Poison Control Center right away.

  • Ask Doctor

    When Pregnant or breast-feeding.

  • Keep Oot Of Reach Of Children

    Keep Oot Of Reach Of Children

  • Directions

    1. Apply 1 ML(few drops) directly onto scalpon the hairloss area.
    2. Use fingertips to massage solution intoskin/hair for2-3 minutes.
    3. Allow time for hair to fully absorb GrowthOil For bestresults, use twice daily onclean dry hair.

  • Other information

    Before use, read all information on thecarton Store at controlled room temperature20 to 25 C (68 to 77°F)

  • Inactive ingredients

    Biotin
    Caffeine
    Niacinamide.

  • PRINCIPAL DISPLAY PANEL

    labellabellabel

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL TOPICAL SERUM 
    hair essential oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83872-011
    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
    24-HOMO-1,25-DIHYDROXYVITAMIN D3 (UNII: F35KTH803S)  
    BIOTIN (UNII: 6SO6U10H04)  
    CAFFEINE (UNII: 3G6A5W338E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83872-011-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/29/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/29/2024
    Labeler - Shenzhen Xiaomai Manufacturing Co., Ltd. (712999147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Xiaomai Manufacturing Co., Ltd.712999147manufacture(83872-011)