FDA Label for Bosley Woman 2 Minoxidil Topical Solution

View Indications, Usage & Precautions

Bosley Woman 2 Minoxidil Topical Solution Product Label

The following document was submitted to the FDA by the labeler of this product Scientific Hair Research, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




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?



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