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Keeps Minoxidil Topical Solution, 5%

minoxidil solution · Keeps Minoxidil Topical Solution, 5% is an arteriolar vasodilator (over-the-counter) containing minoxidil solution, made by Keeps (30 Madison).

Type
Over the counter
Drug class
Arteriolar Vasodilator
Route
Topical
Manufacturers
1

to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

Drug facts

Generic name
minoxidil solution
Active ingredients
Minoxidil
Dosage forms
Solution
Label holder
Keeps (30 Madison)
FDA application
ANDA217998
Label updated
08/07/2025

Active ingredients

Minoxidil USP 5% w/v

Purpose

Hair regrowth treatment for men

Uses

To regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

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 5% minoxidil topical solution for men In clinical studies with mostly white men aged 18 to 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 20º to 25º C (68º to 77º F)

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. 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 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 right away. (1-800-222-1222)

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. 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

Ask a doctor before use

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

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

Pregnancy or breastfeeding

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 right away. (1-800-222-1222)

Inactive ingredients

Alcohol (28.86% v/v), propylene glycol, purified water

Questions?

Call toll-free 1-866-923-4914

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Solution50 mg/mLtopical1

Manufacturers and labels

1 FDA label

  • Keeps (30 Madison)Shown hereANDA217998 · Label 08/07/2025 · NDC 71713-102Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Keeps Minoxidil Topical Solution, 5%: common questions

What is Keeps Minoxidil Topical Solution, 5% used for?
to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
Is Keeps Minoxidil Topical Solution, 5% a prescription drug?
No. Keeps Minoxidil Topical Solution, 5% is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Keeps Minoxidil Topical Solution, 5%?
Yes. Other FDA-listed products with the same active ingredients include Hair Regrowth Treatment, Minoxidil (For Men), Minoxidil for Women, Minoxidil.
Who makes Keeps Minoxidil Topical Solution, 5%?
Keeps (30 Madison) lists Keeps Minoxidil Topical Solution, 5% with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/07/2025 · Label text is shown as published by the manufacturer. Not medical advice