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
Updated May 21, 2020
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- ACTIVE INGREDIENT
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 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BOSLEY MD REGULAR STRENGTH FOR WOMEN
minoxidil 2% solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69113-001 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 ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69113-001-01 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)