Label: JARDIENT 5% MINOXIDIL HAIR GROWTH SERUM- 5% minoxidil hair growth serum liquid

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

Drug Label Information

Updated November 20, 2023

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  • Active Ingredient

    Minoxidil 5%

  • Purpose

    Hair regrowth treatment for men and women

  • Use

    to regrow hair on the top of the scalp(vertex only, see pictures on side of this carton)

  • Warnings

    For external use only. Avoid contact with eyes. If irritation or rash occurs, discontinue use and consult a healthcare professional.

  • Do not use

    Do not use it if you are under 18 years of age.
    Please do not use it on other parts of the body.
    Do not use it if you have no family history of hair loss.
    Do not use it if you have a red, inflamed, infected, or painful scalp.
    Do not apply to other parts of the body.

  • Stop Use

    Stop using and ask a doctor if
    irritation or allergic reactions develop.
    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 occurs
    you do not see hair regrowth in 4 months

  • Ask Doctor

    Stop using and ask a doctor if
    irritation or allergic reactions develop.
    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 occurs
    you do not see hair regrowth in 4 months

  • Keep Oot Of Reach Of Children

    Keep out of reach of children.
    In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

  • Directions

    Apply one milliliter with a dropper for men two times / for women one time a day directly onto the scalp in the hair loss area.
    Using more or more often will not improve results.
    Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

  • Other information

    Store in a cool, dry place, away from direct sunlight.

  • Inactive ingredients

    Water, Biotin, Propylene Glycol, Citric Acid, Caffeine, Niacinamide, Hydrolyzed Collagen, Polysorbate, Panthenol, Stearyl alcohol, Sodium lauroyl sarcosinate, Ginseng extract, Hydrogenated castor oil

  • Questions

    If you are not satisfied with our product, please contact us at Support@jardient.com. We will do our best to resolve any issues you may have.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    JARDIENT 5% MINOXIDIL HAIR GROWTH SERUM 
    5% minoxidil hair growth serum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83596-002
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 21 (UNII: 59IO08SBZU)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    WATER (UNII: 059QF0KO0R)  
    BIOTIN (UNII: 6SO6U10H04)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CAFFEINE (UNII: 3G6A5W338E)  
    COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83596-002-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535711/19/2023
    Labeler - Aramode (963192477)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramode963192477manufacture(83596-002)
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