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hers hair regrowth treatment
minoxidil · hers hair regrowth treatment is an arteriolar vasodilator (over-the-counter) containing minoxidil, made by Hims Inc.
- Type
- Over the counter
- Drug class
- Arteriolar Vasodilator
- Route
- Topical
- Manufacturers
- 1
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, Solution
- Label holder
- Hims Inc
- FDA application
- ANDA091344
- Label updated
- 05/14/2025
Active ingredients
Minoxidil 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 if you have 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 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 6 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
- 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
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Inactive ingredients
Butane, butylated hydroxytoluene, cetyl alcohol, citric acid, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40B, stearyl alcohol
Questions?
1-800-368-0038
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Aerosol, foam | 5 g/100g | topical | 1 |
| Solution | 2 g/100mL | topical | 1 |
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
2 FDA labels
- Hims IncShown hereANDA091344 · Label 05/14/2025 · NDC 71730-813Full label
- Hims IncANDA075357 · Label 04/25/2025 · NDC 71730-023Full 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
hers hair regrowth treatment: common questions
- What is hers hair regrowth treatment used for?
- to regrow hair on the top of the scalp (see pictures on side of this carton)
- Is hers hair regrowth treatment a prescription drug?
- No. hers hair regrowth treatment is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as hers hair regrowth treatment?
- Yes. Other FDA-listed products with the same active ingredients include Hair Regrowth Treatment, Minoxidil (For Men), Minoxidil for Women, Minoxidil.
- Who makes hers hair regrowth treatment?
- Hims Inc lists hers hair regrowth treatment with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 05/14/2025 · Label text is shown as published by the manufacturer. Not medical advice