Label: EXT HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% solution

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

Drug Label Information

Updated September 10, 2019

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

  • ACTIVE INGREDIENT

  • USE

    Use to regrow hair on the scalp

  • PURPOSE

    Hair regrowth treatment

  • WARNINGS

    For external use only.

    Flamable: Keep away from fire of flame.

  • DO NOT USE

    Do not use if:

    • Your degree of hair loss is different than shown on the side of this carton, because this product may not work for you
    • 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 or children
    • Your scalp is red, inflamed, infected, irritated, or painful
    • You use other medicines on the scalp
  • ASK DOCTOR

    Ask a doctor before use if you have heart disease

  • WHEN USING

    • 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 cool tap water
    • Some people have expereinced changes in hair color and/or texture
    • It takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results
    • The amount of hair regrowth is different for each person. This product will not work for everyone.
  • STOP USE

    Stop use and ask a doctor if

    ■ side eects occur. You may report side eects to FDA at

    1.800.FDA.1088

    ■ 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

  • PREGNANCY OR BREAST FEEDING

    May be harmful if 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

    Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
    Using more or more ofthen will not improve results
    Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

  • OTHER SAFETY INFORMATION

    • See hair loss pictures on the side of this carton
    • Before use, read all information on carton and enclosed leaflet
    • Keep the carton. It contains important information
    • In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
    • Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)
  • INACTIVE INGREDIENT

    Inactive ingredients

    Alcohol, Propylene Glycol, Purified Water

  • PRINCIPAL DISPLAY PANEL

    box label

  • INGREDIENTS AND APPEARANCE
    EXT HAIR REGROWTH TREATMENT FOR WOMEN 
    minoxidil 2% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70150-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70150-001-011 in 1 BOX09/10/2019
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07817609/10/2019
    Labeler - TTEM, LLC (079997910)