Regoxidine (For Women)

Regoxidine (For Women) is an FDA-registered drug product whose active ingredient is MINOXIDIL. It is labelled by Innovus Pharmaceuticals, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 57483-540, application ANDA209074, label effective 20221216. It is one of 90 FDA drug label records sharing the active ingredient MINOXIDIL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MINOXIDIL are most often described in connection with: regrow hair, scalp see, pictures side. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use 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).

FDA lists 90 drug label records with MINOXIDIL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Regoxidine (For Women) used for?
Use to regrow hair on the top of the scalp (see pictures on side of this carton)

Who makes Regoxidine (For Women)?
Innovus Pharmaceuticals, Inc. is the labeler of record for Regoxidine (For Women). 90 FDA label records share the active ingredient MINOXIDIL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Regoxidine (For Women) come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Regoxidine (For Women) prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MINOXIDIL?
Yes. 90 FDA drug label records list MINOXIDIL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Regoxidine (For Women) been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.