FDA Label for Bosley Minoxidil Topical Solution 2 For Women
View Indications, Usage & Precautions
Bosley Minoxidil Topical Solution 2 For Women 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 2.0%w/v
Purpose
Hair regrowth treatment for women
Use
to regrow hair on the top of the scalp (vertex only, see picture on side of box)
Warnings
For external use only.
Flammable:keep away from fire or flame
Do Not Use If:
- your amount of hair loss is different than that shown on the side of this box 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 and children.
- your scalp is red, inflamed, infected, irritated, or painful
- you use other medications 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 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 or redness occurs
- unwanted facial hair growth occurs
- you do not see hair regrowth in 4 months
May be harmful if used
When Pregnant Or Breastfeeding.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
- apply one ml. (6 sprays) 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 box
- before use, read all information on carton and enclosed insert
- keep carton, it contains important information
- in clinical studies with mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using woman's minoxidil topical solution 2% for 8 months; 19% had moderate regrowth; 40% had minimal regrowth. This compares with 7% of women reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal 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 us at 1-800-267-5391 or visit website at www.bosleymd.com
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