Minoxidil
Topical hair regrowth treatment. Sold as Men's Rogaine Extra Strength, Women's Rogaine.
Topical minoxidil is the only hair loss treatment in this category available without a prescription. It is sold under a Drug Facts label, in separate products for men and for women, and those labels differ in formulation and in the directions for use.
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | Status for this use | Supply | Label version |
|---|---|---|---|
| Men's Rogaine Extra StrengthKenvue Brands LLC | Approved for hair loss | Over the counter | 6 September 2024 |
| Women's RogaineKenvue Brands LLC | Approved for hair loss | Over the counter | 13 November 2024 |
How it works
Written by us
Minoxidil was first developed as an oral medication for high blood pressure, and hair growth was observed as a side effect. The over-the-counter Drug Facts label does not describe a mechanism; it states the purpose of the product, which is hair regrowth treatment.
What this product is for
The approved uses, as worded in the label.
From the FDA label
Men's Rogaine Extra Strength
- Hair regrowth treatment for men
- to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Women's Rogaine
- Hair regrowth treatment for women
- to regrow hair on the top of the scalp (see pictures on side of this carton)
Active ingredient
The presentations and strengths listed in the label.
From the FDA label
Men's Rogaine Extra Strength
Minoxidil 5% w/v
Women's Rogaine
Minoxidil 5% w/w (without propellant)
Directions
What the label states about administration. It is not a dosing instruction for any individual.
From the FDA label
Men's Rogaine Extra Strength
- 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
Women's Rogaine
- 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
Stop use and ask a doctor if
The adverse reactions the label reports as most common.
From the FDA label
Men's Rogaine Extra Strength
- 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
Women's Rogaine
- 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
Warnings
The warnings and precautions section of the label.
From the FDA label
Men's Rogaine Extra Strength
- Ask a doctor before use if you have heart disease
- 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.
Women's Rogaine
- Ask a doctor before use if you have heart disease
- 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 if
Situations in which the label states the medication must not be used.
From the FDA label
Men's Rogaine Extra Strength
- 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. 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 the scalp
Women's Rogaine
- 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
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
From the FDA label
Men's Rogaine Extra Strength
May be harmful if used when pregnant or breast-feeding.
Women's Rogaine
May be harmful if used when pregnant or breast-feeding.
Generic or brand
Written by us
Generic topical minoxidil is approved and sold widely, including under retailer own brands. The active ingredient and its concentration are printed on every Drug Facts label.
The FDA label database lists 19 approved generic applications for this ingredient.
What affects the cost
Written by us
Because it is sold over the counter and has many approved generics, minoxidil is the least expensive option in this category. This site does not track prices and does not link to sellers.
Common questions
- Do the men's and women's products differ?
- They are separate FDA approvals with separate Drug Facts labels, and the labels differ in formulation and in the directions for use. Compare the active ingredient and directions sections on this page rather than assuming they match. The men's label also states that the product is not intended for frontal baldness or a receding hairline.
- What does the label say about how long it takes?
- The men's label states that results may occur at 2 months with twice a day use, and that some men may need to use the product for at least 4 months before results are seen. It also states that continued use is necessary or hair loss will begin again.
- Is oral minoxidil the same thing?
- No. Oral minoxidil is approved for high blood pressure, not for hair loss, and it carries a boxed warning. The pages here cover the topical products approved under a Drug Facts label for hair regrowth.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Men's Rogaine Extra Strength
Kenvue Brands LLC. Label version 5, effective 6 September 2024.
FDA prescribing information for Women's Rogaine
Kenvue Brands LLC. Label version 6, effective 13 November 2024.
Page last updated: 29 July 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.