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Active ingredient communityMinoxidil
Drug classVasodilator
Referenced productWomens Rogaine Unscented
Labeler / manufacturerKENVUE BRANDS LLC
Route in selected labelTOPICAL
Label effective date2024-11-13
Drug reference
About Minoxidil
Minoxidil is classified as vasodilator. Brand names associated with this community include Rogaine, Loniten.
The label displayed here is for Womens Rogaine Unscented. Other brands or formulations may have different approved uses, doses and safety information; their names are included for navigation, not to imply interchangeability.
to regrow hair on the top of the scalp (see pictures on side of this carton)
Dosage and administration — label text
see enclosed booklet for complete directions on how to use
apply half a capful once daily directly to the scalp in the hair loss area
massage into scalp with fingers, then wash hands well
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
Warnings
Minoxidil 5% w/w (without propellant)
Storage and handling
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.
store at controlled room temperature 20º to 25º C (68º to 77º F)
contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).
do not use more than directed
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 3 months with once daily use. For some women, you may need to use this product once a day for at least 6 months before you see results.
the amount of hair regrowth is different for each person. This product will not work for all women.
Do not use
your degree of hair loss is different than that shown on side of this carton 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 medicines on the scalp
Ask a doctor before use
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 6 months
Minoxidil, sold under the brand names Loniten and Rogaine among others, is a vasodilator medication used for the treatment of high blood pressure and hair loss. It may also be used off-label to promote beard growth and treat nail problems. The drug promotes hair growth, but its effects are fully reversible and it does not prevent hair loss long term. It is available as a generic medication by prescription in oral tablet form and over-the-counter as a topical liquid or foam. Oral minoxidil is used at high doses to treat high blood pressure and at low doses to treat hair loss, while topical minoxidil is used exclusively for hair loss and related indications. Extended-release oral minoxidil and sublingual minoxidil formulations for hair loss are also being studied and developed.
Side effects of oral minoxidil may include low blood pressure, water retention and edema, salt retention, rapid heartbeat, dizziness, lightheadedness, headaches, excessive hair growth, and temporary hair shedding. Adverse effects of topical minoxidil include skin irritation, itching, dandruff, and temporary hair shedding. Rare but serious adverse effects of oral minoxidil include pericardial effusion, pleural effusion, cardiac tamponade, other cardiovascular complications, and pseudoacromegaly. Minoxidil is a prodrug of minoxidil sulfate, which acts as a KATP potassium channel opener to widen blood vessels and increase hair growth. The effects of minoxidil are dose-dependently similar to the symptoms of Cantú syndrome.
Minoxidil was discovered in 1963 and was introduced for treatment of high blood pressure in 1971. In 1971, researchers unexpectedly discovered that minoxidil causes hair growth, resulting in it being repurposed for treatment of hair loss and approved in topical form for this use in 1988. Topical minoxidil became available over-the-counter in 1996. Low-dose oral minoxidil (LDOM) emerged for treatment of hair loss in 2015 and dramatically increased in popularity starting in 2022. Extended-release oral minoxidil and sublingual minoxidil were developed in the 2020s for hair loss and are in late-stage trials. Aside from its use in humans, minoxidil is extremely toxic to cats and dogs even in small amounts.
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