Active Ingredient
Minoxidil 5% w/v
The following Structured Product Label (SPL) was submitted to the FDA by Anhui Cao Coral Biology Science And Technology Co., Ltd for the product Men S Extra Strength Minoxidil Hair Regrowth Treatment (NDC 83091-002). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5% w/v
Hair regrowth treatment for men
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
For external use only
For use by men only
you are a woman.
your amount of hair loss is different than that shown on side of this carton, or your hair loss is on the front of the scalp.5% Minoxidil topical solution 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 th scalp.
do not apply on other parts of the body.
avoid contact with eyes. In case of accidental contact, rinse eyes with large amount 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.
chest pain, rapid heart beat, 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
If you have heart desease
If swallowed, get medical help or contact a Poison Control Center right away.
prime the sprayer by holding the bottle upright and pump the sprayer 5times to ensure delivery of full spray. Do not inhale mist.
apply 1mL with the sprayer (5spraye) 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.
see hair loss pictures on side of this carton.
Before use, read all information on the 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 5% minoxidil topical solution for men.
in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution.
store at controlled room temperature 20° to 25°C (68° to 77°F).
alcohol, propylene glycol, purified water
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