Label: 5% MINOXIDIL SPRAY.- 5% minoxidil spray spray

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

Drug Label Information

Updated October 7, 2023

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  • Active Ingredient

    Minoxidil 5%

  • Purpose

    Hair Regrowth Treatment

  • Use

    to regrow hair on the top of the scalp

  • Warnings

    For external use only

    Keep away from fire and flame

    Avoid contact with eyes

  • Do not use

    You have no family history of hair loss,hair loss is sudden and/or patchy

    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

    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 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

    Apply 1ml(5 Sprays) twice a day.Once in the morning and another time in the evening before bed

    Spray directly on top of the scalp in the area to be treated

    Discontinuing use may result in hair loss

  • 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

    Tomumcs@gmail.com

  • PRINCIPAL DISPLAY PANEL

    01

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL SPRAY. 
    5% minoxidil spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-014
    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
    ALCOHOL (UNII: 3K9958V90M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83299-014-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535710/07/2023
    Labeler - Consilii LLC (118891890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consilii LLC118891890label(83299-014) , manufacture(83299-014)
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