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 January 18, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
-
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
-
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BOSLEY MD REGULAR STRENGTH FOR WOMEN
minoxidil 2% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69113-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 2 g in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69113-004-01 2 in 1 BOX 05/21/2020 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078176 05/21/2020 Labeler - Scientific Hair Research, LLC (961897647)