Bosley Woman 2 Minoxidil Topical Solution
FDA Label NDC 69113-432
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scientific Hair Research, Llc for the product Bosley Woman 2 Minoxidil Topical Solution (NDC 69113-432). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, use, warnings, do not use if:, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Minoxidil 5% w/v
Purpose
Hair regrowth treatment
Use
to regrow hair on the scalp
Warnings
For external use only
Flammable:Keep away from fire or flame
Do Not Use If:
• your degree of hair loss is more than that shown on the side of this carton. Minoxidil topical solution 2% may not work. • 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 on and children • your scalp is red, inflamed, infected, irritated, or painful • you use other medicines on the scalp
Ask A Doctor Before Use If You Have
heart disease
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. You may need to use this product 2 times a day 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 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 of redness occurs
• unwanted facial hair growth occurs
• you do not see hair regrowth in 4 months
May be harmful if used when pregnant or breast-feeding.
Keep Out Of Reach Of Children.
If swallowed, get medical help, or contact a Poison Control Center right away.
Directions
• apply one mL with dropper 2 times a daydirectly onto the scalp in the hair loss area
• using more or more often will not improve results
• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Other Information
• see hair loss pictures on side of this carton
• before use, read all information on carton and enclosed leaflet
• keep the carton, It contains important information.
• In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution 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 regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minomal regrowth). • store at controlled room temperature 20° to 25°C (68° to 77°F).
Inactive Ingredients
Alcohol, Propylene Glycol, Purified Water
Questions Or Comments?
Call toll-free 1-800-BOSLEY1
- Visit Website at www.bosleymd.com
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