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Minoxidil for Women
minoxidil · Minoxidil for Women is an arteriolar vasodilator (over-the-counter) containing minoxidil, made by 9 manufacturers.
- Type
- Over the counter
- Drug class
- Arteriolar Vasodilator
- Route
- Topical
- Manufacturers
- 9
to regrow hair on the top of the scalp (see pictures on side of this carton)
Drug facts
- Generic name
- minoxidil
- Active ingredients
- Minoxidil
- Drug class
- Arteriolar Vasodilator
- Dosage forms
- Aerosol, foam
- Label holder
- CARDINAL HEALTH 110, LLC. DBA LEADER
- FDA application
- ANDA218616
- Label updated
- 04/13/2026
Active ingredients
Minoxidil USP 5% w/w (without propellant)
Purpose
Hair regrowth treatment for women
Uses
To regrow hair on the top of the scalp (see pictures on side of this carton)
Directions
See enclosed leaflet 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
For external use only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.
Do not use
If 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
Heart disease
When using this product
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.
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 6 months
Pregnancy or breastfeeding
May be harmful if used when pregnant or breast-feeding.
Keep out of reach of children
And pets. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).
Inactive ingredients
Alcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol Questions? Call toll-free 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Women’s Rogaine ®. Cardinal Health ™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 Made in India Code: TS/DRUGS/58039/2020 CIN 6103956 REV. 02/26
Forms and strengths
From the FDA NDC Directory · 9 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Aerosol, foam | 50 mg/g | topical | 9 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 44,659 reports that list minoxidil, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Adverse drug reaction8,585
- Drug ineffective7,760
- Alopecia3,801
- Application site pruritus2,926
- Off label use2,275
- Overdose1,461
- Application site irritation1,420
- Application site pain1,413
- Hair texture abnormal1,409
- Headache1,342
To report a side effect, use FDA MedWatch.
Manufacturers and labels
9 FDA labels
- CARDINAL HEALTH 110, LLC. DBA LEADERShown hereANDA218616 · Label 04/13/2026 · NDC 70000-0753Full label
- BosleyMDANDA208092 · Label 03/24/2026 · NDC 69113-502Full label
- CVS PharmacyANDA209074 · Label 04/06/2026 · NDC 51316-213Full label
- Kroger CompanyANDA209074 · Label 10/25/2022 · NDC 59450-211Full label
- SCIENTIFIC HAIR RESEARCH, LLCANDA209074 · Label 07/03/2024 · NDC 69113-129Full label
- SPAZI INC.ANDA209074 · Label 01/23/2024 · NDC 82376-6007Full label
- TARGET CorporationANDA209074 · Label 04/16/2024 · NDC 11673-158Full label
- Virtue Labs, LLCANDA209074 · Label 07/17/2025 · NDC 80855-201Full label
- Walgreen CompanyANDA209074 · Label 10/10/2022 · NDC 0363-9091Full 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
Minoxidil for Women: common questions
- What is Minoxidil for Women used for?
- to regrow hair on the top of the scalp (see pictures on side of this carton)
- Is Minoxidil for Women a prescription drug?
- No. Minoxidil for Women is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Minoxidil for Women?
- Yes. Other FDA-listed products with the same active ingredients include Hair Regrowth Treatment, Minoxidil (For Men), Minoxidil, Minoxidil 5% (For Men).
- Who makes Minoxidil for Women?
- 9 manufacturers list Minoxidil for Women with the FDA, including CARDINAL HEALTH 110, LLC. DBA LEADER, BosleyMD, CVS Pharmacy.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/13/2026 · Label text is shown as published by the manufacturer. Not medical advice