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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
- Drug class
- Arteriolar Vasodilator
- 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 form | Strength | Route | NDCs |
|---|---|---|---|
| Solution | 50 mg/mL | topical | 1 |
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
- Class IIDrug02/01/2023Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.Pharmacy Innovations · Lack of Assurance of Sterility: FDA inspection revealed insanitary...
- Class IIDrug08/05/2020Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finasteride 0.25%), 0.5 FL OZ (15...MasterPharm LLC · 4 products · Lack of Processing Controls (lack of assurance of conformity to...
- Class IDrug07/08/2020Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug...MasterPharm LLC · Super-potent Drug: This recall has been initiated due to the...
- Class IIDrug03/22/2017MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena...Synergy Rx · Lack of Assurance of Sterility: There are also CGMP Deviations.
- Class IIDrug07/20/2016MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACYMedaus, Inc. · Lack of Assurance of Sterility
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