Active Ingredient(S)
minoxidil 5%
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Youbente E-commerce Co., Ltd for the product 3rx Minoxidil Hair Regrowth Treatment For Men (NDC 84432-001). 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(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
minoxidil 5%
Hair regrowth treatment for men
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
For extermal use only. For use by men only.
Flammable: Keep away from fire or flame
■youare a woman
■your amount of hair loss is diferent than that shown on the sideof
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
hairlineyou have no family history of hair loss
■yourhair loss is suddenor patchy
■youdo not knowthe reason for your hair less
■youareunder 18years of age. Do notuse on babies and
children.
■yourscalp is red, inflamed, infected, itated or painful
■youuse other medicines onthe scalp
■donot apply on other parts of the body
■avoid contact with the eyes. In case of accidental contact, rinse
eyes with large amounts of tap water.
■some people have experienced changes in hair color and 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 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 heartbeat, faintness, or dizziness occur
■sudden, unexplained weight gain occurs
■your hands or feet swell
■scalp initation or redness occurs
■unwanted facial hair growthoocurs
■youdo not see hair regrowth in 4 months
Keep out of reach of children. If swallowed, get medical help or
oontact a Poison Control Center right away
■apply one mLwith dropper 2 times a day direty onto the scalpin the hair loss
■using more or more often will not improve results
■continued use is neoessary 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 carton and enclosed lealflet
■keepthe carton. It contains important infomation.
■hair regrowth has not been shown to last longer than 48 weeks in
large dlinical trials with continuous treatment with minoxidil topical solution 5% for men
■indlinical studies with mosty white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for
men provided more hair regrowth than minoxidil topical solution 2%
■store at20° to 25°C (68° to 77°F). Keep tightyclosed.
aqua, biotin, ollagen, panax ginseng extract ginger extract, safflower extract, cortex dictamni extract, ligusticum chuanxiong
extract, licorioe extract, burdock root extract, angelica sinensis root extract, platycladus orientalis leaf extract, polygonum
muliflorum root extract, aloohol, capsaicin
* Please review the disclaimer below.