Label: BOURN HAIR REGROWTH TREATMENT FOR MEN- minoxidil 5% solution

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

Drug Label Information

Updated February 9, 2021

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

  • ACTIVE INGREDIENT

    Minoxidil 5% w/v

  • PURPOSE

    Hair regrowth treatment for men

  • USE

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

  • WARNINGS

    For external use only. For use by men 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.

    Minoxidil topical solution 5% 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 chances 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 all men.

  • STOP USE

    Stop use and ask a doctor if

    ■ 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. (1-800-222-1222)

  • DIRECTIONS

    • apply 1 mL with dropper 2 times 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

    • see hair loss pictures on side of this carton

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

    • keep the carton. It contains important information.

    • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with

    continuous treatment with 5% minoxidil topical solution for men

    •in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5%

    for men provided more hair regrowth than minoxidil topical solution 2%

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

  • INACTIVE INGREDIENT

    alcohol, propylene glycol, purified water

  • QUESTIONS

    Questions or comments? (909) 517-1177

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BOURN HAIR REGROWTH TREATMENT FOR MEN 
    minoxidil 5% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81553-001
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81553-001-016 in 1 BOX02/04/2021
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623902/04/2021
    Labeler - Octri, Inc. (070111400)