Label: BOSLEY MD EXTRA STRENGTH FOR MEN- minoxidil 5% solution
- NDC Code(s): 69113-003-01
- 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
■ 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. 5% Minoxidil Topical Solution 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
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 changes 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
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
OTHER SAFETY INFORMATION
- See hair loss pictures on side of this carton
- Before use, read all information on carton and enclosed leaflet
- Keep this 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 18-19 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
- Store at controlled room temperature between 68° - 77°F (20°-25°C).
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
BOSLEY MD EXTRA STRENGTH FOR MEN
minoxidil 5% solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69113-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 5 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:69113-003-01 2 in 1 BOX 05/21/2020 1 2 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 ANDA076239 05/21/2020 Labeler - Scientific Hair Research, LLC (961897647)