Label: 5% MINOXIDIL HAIR GROWTH OIL liquid

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

Drug Label Information

Updated October 9, 2023

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  • Active Ingredient

    Minoxidil 5%

  • Purpose

  • Use

    to regrow hair on the scalp

  • Warnings

    For external use only.

  • Do not use

    Pregnant, Feeding, Heart sensibility, Super-sensitive skin, an open wound since that can cause irritations.
    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 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.
    The product will not work for everyone.

  • Stop Use

    Chest pain, rapid heartbeat, faintness, or dizziness occurs.
    Sudden, unexplained weight gain occurs.
    Your hands or feet swell.
    Scalp irritation or redness occurs.
    Unwanted facial hair growth develops.
    No hair regrowth is seen in 4 months.

  • Ask Doctor

    Chest pain, rapid heartbeat, faintness, or dizziness occurs.
    Sudden, unexplained weight gain occurs.
    Your hands or feet swell.
    Scalp irritation or redness occurs.
    Unwanted facial hair growth develops.
    No hair regrowth is seen in 4 months.

  • Keep Oot Of Reach Of Children

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    Apply 2-4 drops directly to the treated scalp area.
    Massage into the scalp and wash hands thoroughly.
    Visible results may take 2 months with twice-daily application. For some, at least 4 months of use may be needed.Effectiveness varies.

  • Other information

    Before use, read all information on the carton.
    Store at a controlled room temperature of 20 to 25°C (68 to 77°F).
    Contents under pressure. Do not puncture or incinerate the container. Do not expose to heat or store at temperatures above 120°F (49 °C).

  • Inactive ingredients

    AQUA、NIACINAMIDE、GLYCERIN、PROPYLENE GLYCOL、CARNITINE、ACETYL TETRAPEPTIDE-3

  • Questions

    venanocics@gmail.com

  • PRINCIPAL DISPLAY PANEL

    01

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR GROWTH OIL 
    5% minoxidil hair growth oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-017
    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
    ACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARNITINE (UNII: S7UI8SM58A)  
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83299-017-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product10/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535710/08/2023
    Labeler - Consilii LLC (118891890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consilii LLC118891890label(83299-017) , manufacture(83299-017)
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