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

  • NDC Code(s): 69113-004-01
  • 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 picture 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 all women.
  • 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.

  • DOSAGE & ADMINISTRATION

    • Apply one mL (6 sprays) 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 o C (68 o to 77 oF)
  • INACTIVE INGREDIENT

    Alcohol, Propylene Glycol, Purified Water

  • QUESTIONS

    Questions or comments? Call your health professional or BosleyMD 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:69113-004
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69113-004-012 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)