Drug Facts

Active ingredient

Minoxidil, USP 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.
Flammable: Keep away from fire or flame

Do not use 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
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 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. 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 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 breast-feeding.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

apply one mL with dropper 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 leaflet
keep the 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 minoxidil topical solution 5% for men
In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredients

alcohol (30% v/v), propylene glycol (50% v/v), purified water

Principal display panel

FOR MEN

EXTRA STRENGTH

NOT FOR USE BY WOMEN

MINOXIDIL TOPICAL SOLUTION, USP 5%

Hair Regrowth Treatment

FOR BEST RESULTS APPLY DIRECTLY TO SCALP TWICE DAILY

FOR EXTERNAL USE ONLY

ONE MONTH SUPPLY - ONE 60 mL (2fl oz) BOTTLE

Distributed by Seiseidou America

10880 Wilshire Blvd., Suite 1101

Los Angeles, CA 90024

Package label

FORTERO Hair Regrowth Treatment

Minoxidil Topical Solution for Men