Drug Facts Label for Minoxidil Topical Solution 5% for Men
(FDA Suggested/Required Packaging)

Drug Facts:
Active ingredient:
Minoxidil 5% w/v
Purpose:
Hair regrowth treatment for men
Use:
To regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Warnings:
For external use only. For use by men only.
Flammability warning:
Keep away from fire or flame [Include if product meets the
criteria in 16 CFR 1500.3(b)(10)]
Do not use Minoxidil if:
you are a woman
your amount of hair loss is different than that shown on the side of this carton or your
hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for
frontal baldness or receding hairline.
you have no family history of hair loss
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.
scalp is red, inflamed, infected, irritated, or painful
you use other medicines on the scalp
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.
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 and ask a doctor if:
chest pain, rapid heart beat, faintness, or dizziness occurs
sudden, unexplained weight gain occurs
your hands or feet swell
scalp irritation or redness occurs
you get unwanted facial hair growth
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 for Minoxidil:
apply one mL with dropper or sprayer 2 times a day directly 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 booklet
keep the carton. It contains important information.
clinical research in mostly white men aged 18-49 years with moderate degrees of hair loss, showed that minoxidil topical solution 5% for men provides more hairregrowth than minoxidil topical solution 2% for men. Hair regrowth has not beenshown to last longer than 48 weeks of continuous treatment in large clinical trials with minoxidil topical solution 5% for men.


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