Label: MINOXIGAINE- minoxidil liquid

  • 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 March 26, 2019

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

  • ACTIVE INGREDIENT

    Minoxidil 5%

  • PURPOSE

    Hair Regrowth Treatment for Men

  • INDICATIONS & USAGE

  • WARNINGS

    For external use only. 
    Flammable: Keep away from fire or flame
    Do not use if:
    • You have no family history of hair loss
    • Your hair loss is sudden and/or patchy

    • Your hair loss is associated with childbirth
    • You do not know the reason for your hair loss
    • You are under 18 years of age. Do not use on babies and children
    • Your scalp is red, inflamed, irritated or painful
    • You use other medicines on the scalp
    Ask a doctor before use if you have heart disease
    When using this product
    • Do not apply on other parts of the body
    • Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of tap water
    • Some people have experienced changes in hair color and/or texture    it takes time to regrow hair. 
    • You may need to use this product 2 times a day for at least 4 months before you see results
    • The amount of hair regrowth is different for each person.
    • This product may not work for everyone.
    Stop use and/or ask a doctor if
    • Chest pain, rapid heartbeat, faintness, dizziness or 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
    May be harmful is used when pregnant or breast-feeding.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Using dropper, apply one mL directly onto the scalp in the hair loss area

    For best results use twice daily on dry towel dried hair.

    Use fingertips to massage solution into skin

  • Other Information

    • Store at controlled room temperature 68º to 77ºF (20º- 25ºC)

  • Other Ingredients

    Azelaic Acid, Retinol, Caffeine, Biotin, Saw Palmetto Extract, Nettle Extract 10:1, Pygeum Bark Extract, Water, SD Alcohol, Propylene Glycol, Gransolve DMI, Fresh Blue Agave, Zinc Sulfate, Vitamin B6.

  • QUESTIONS

    Questions or comments:
    1-281-454-3563

  • PRINCIPAL DISPLAY PANEL

    Minoxigaine

  • INGREDIENTS AND APPEARANCE
    MINOXIGAINE 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72965-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AZELAIC ACID (UNII: F2VW3D43YT)  
    RETINOL (UNII: G2SH0XKK91)  
    CAFFEINE (UNII: 3G6A5W338E)  
    BIOTIN (UNII: 6SO6U10H04)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    URTICA DIOICA (UNII: 710FLW4U46)  
    PYGEUM (UNII: 709HYI14M4)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    PYRIDOXINE (UNII: KV2JZ1BI6Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72965-001-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2019
    Labeler - Hairgenics LLC (108751481)
    Registrant - PHARMA-NATURAL INC. (138059287)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHARMA-NATURAL INC.138059287manufacture(72965-001)