Label: BOSLEY MD REGULAR STRENGTH FOR WOMEN- minoxidil 2% solution

  • NDC Code(s): 69113-001-01
  • Packager: Scientific Hair Research, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 21, 2020

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

  • ACTIVE INGREDIENT

    Minoxidil 2% w/v

  • PURPOSE

    Hair regrowth treatment

  • USE

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

  • WARNINGS

    For external use only.

    Flamable: Keep away from fire of flame.

  • DO NOT USE

    Do not use if:

    Your amount 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

    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 expereinced changes in hair color and/or texture
    • It takes time to re-grow hair. 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

    ■ 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 immediately.

  • 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 Minoxidil Topical Solution 2% 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

    Alcohol, Propylene Glycol, Purified Water

  • QUESTIONS

    Questions or comments? Call youre health professional or BosleMD at 1(800)BOSLEY1

  • PRINCIPAL DISPLAY PANEL

    Box Label

  • INGREDIENTS AND APPEARANCE
    BOSLEY MD REGULAR STRENGTH FOR WOMEN 
    minoxidil 2% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69113-001
    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:69113-001-012 in 1 BOX05/21/2020
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07817605/21/2020
    Labeler - Scientific Hair Research, LLC (961897647)