Regenpure Precision

Regenpure Precision is an FDA-registered drug product whose active ingredient is MINOXIDIL. It is labelled by Salonceuticals, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 71290-813, application ANDA076239, label effective 20170306. 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 vertex, only 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 (vertex only, see pictures on side of carton).

DIRECTIONS: • Apply 1 mL with sprayer (6 sprays) 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.

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. Minoxidil Topical Solution, 5% 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 medications 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. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. STOP USE AND ASK DOCTOR IF: • Side effects occur: You may report side effects to FDA at 1-800-FDA-1088 or to Salonceuticals, Inc. at 1-877-706-8688 • Chest pain, rapid heartbeat, faintness, or dizziness occurs. • Sudden, unexplained weight gain occurs. • Your hands or feet swell. • Scalp irritation occurs, and continues or worsens. • Unwanted facial hair growth occurs.

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 Regenpure Precision used for?
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).

Who makes Regenpure Precision?
Salonceuticals, Inc. is the labeler of record for Regenpure Precision. 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 Regenpure Precision 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 Regenpure Precision 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 Regenpure Precision 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.