Label: 5% MINOXIDIL SERUM liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2023

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

  • Active Ingredient

    Minoxidil 5%

  • Purpose

    Hair Regrowth Treatment

  • Use

    to regrow hair on the top of the scalp

  • Warnings

    For external use only

    For use on the scalp only

    Avoid contact with eyes

    Keep out of reach of children

    Keep stored at room temperature

  • 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 babies and children

  • When Using

    Do not apply on other parts of the body

    Avoid 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 irritation or redness occurs

  • Ask Doctor

    When Pregnant or breast-feeding

  • Keep Oot Of Reach Of Children

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

  • Directions

    Sterilize the roller with alcohol before use

    Clean the skin area and dry it

    Apply roller gently on your skin, roll diagnoally, horizontally & vertically 4-5 times on target areas

    Apply 2-3 drops of serum directly to the scalp in the area to be treated

    Massage into the scalp with your finger then wash hand thoroughly

    Always perform the test on a small area of the skin to make sure there is no allergic reaction

    Initial shedding may occur as the new hairs push out older strands.

  • Other information

    Before use, read all information on the carton

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

  • Inactive ingredients

    Deionized Water, Propylene Glycol Ethyl Alcohol, Potassium Sorbate, GABA

  • Questions

    mesandycare@gmail.com

  • PRINCIPAL DISPLAY PANEL

    01

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL SERUM 
    5% minoxidil serum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-018
    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
    BIOTIN (UNII: 6SO6U10H04)  
    .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83299-018-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product10/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535710/31/2023
    Labeler - Consilii LLC (118891890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consilii LLC118891890label(83299-018) , manufacture(83299-018)