Label: EXT HAIR REGROWTH TREATMENT FOR MEN 5%- minoxidil 5% 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

    Minoxidil 5% w/v

  • PURPOSE

    Hair regrowth treatment for men

  • USE

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

  • WARNINGS

    Warnings

    For external use only

    Flammable: Keep away from fire or flame

  • DO NOT USE

    Do not use if

    ■ you are a woman ■ your amount of hair loss is dierent than that

    shown on the side of this carton, or your hair loss is on the front of the

    scalp. EXT Hair Regrowth Treatment is not intended for frontal baldness

    or receding hairline. ■ you have no family history of hair loss ■ your

    hair loss is sudden and/or patchy ■ 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, 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

    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 cool tap water.

    ■ some people have experienced 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

    Directions

    ■ apply one mL with dropper 2 times a day directly onto the scalp in

    the area of hair loss

    ■ 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 SAFETY INFORMATION

    Other information

    ■ see hair loss pictures on side of this carton

    ■ before use, read all information on carton and enclosed leaflet

    ■ keep this carton. It contains important information.

    ■In an observational study of 733 male subjects, more than 63% of

    participants found EXT Hair Regrowth Treatment to be eective or very

    eective in hair regrowth.

    ■ store at controlled room temperature between 68° - 77°F

    (20°-25°C). Keep tightly closed.

  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, propylene glycol, purified water

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    EXT HAIR REGROWTH TREATMENT FOR MEN 5% 
    minoxidil 5% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70150-003
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70150-003-011 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
    ANDAANDA07623909/10/2019
    Labeler - TTEM, LLC (079997910)