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Womens Rogaine Unscented
minoxidil · Womens Rogaine Unscented is an arteriolar vasodilator (over-the-counter) containing minoxidil, made by Kenvue Brands LLC.
- 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
- Kenvue Brands LLC
- FDA application
- NDA021812
- Label updated
- 11/13/2024
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 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
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.
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.
Other information
See hair loss pictures on side of this carton before use, read all information on carton and enclosed booklet keep the carton. It contains important information. store at controlled room temperature 20º to 25º C (68º to 77º F) 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
Butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40-B, stearyl alcohol
Questions?
Call toll-free 800-764-2463 or 215-273-8755 (collect) visit www.rogaine.com
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Aerosol, foam | 50 mg/g | topical | 1 |
| Solution | 20 mg/mL | 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
- Kenvue Brands LLCShown hereNDA021812 · Label 11/13/2024 · NDC 69968-0030Full label
- Kenvue Brands LLCNDA019501 · Label 09/06/2024 · NDC 69968-0090Full 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
Womens Rogaine Unscented: common questions
- What is Womens Rogaine Unscented used for?
- to regrow hair on the top of the scalp (see pictures on side of this carton)
- Is Womens Rogaine Unscented a prescription drug?
- No. Womens Rogaine Unscented is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Womens Rogaine Unscented?
- Yes. Other FDA-listed products with the same active ingredients include Hair Regrowth Treatment, Minoxidil (For Men), Minoxidil for Women, Minoxidil.
- Who makes Womens Rogaine Unscented?
- Kenvue Brands LLC lists Womens Rogaine Unscented with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 11/13/2024 · Label text is shown as published by the manufacturer. Not medical advice