Active Ingredient
Minoxidil 5% w/v
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Jianyuan Biological Technology.co.,ltd for the product Regenivade Hair Growth Foam (NDC 81653-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use if:, ask a doctor before use if, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5% w/v
Hair regrowth treatment
to regrow hair
For external use only.
You are a pregnant woman
Your amount of hair loss is different than that shown on the sideof this carton or your hair loss is on the front of the scalp. 5%minoxidil topical foam is not intended for frontal baldness orreceding hairline.
You suffer from metal allergies
You have no family history of hair loss.
You 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.
You scalp is red, inflamed, infected, irritated, or painful.
You use other medicines on the scalp.
you have heart disease
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 withtwice a day usage. For some people, you may need to use thisproduct for at least 4 months before you see results.The amount of hair regrowth is different for each person. Thisproduct will not work for all people.
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 4 months.
May be harmful if used when pregnant or breast-feeding
lf swallowed, get medical help orcontact Poison Control Center right away.
Men: Apply half a capful 2 times a day to the hair loss area.
Women: Apply half a capful 1 time a day to the hair loss area.
Massage to area with fingers, then wash hands well.
Using more and more often will not improve results.
Hair growth has been shown in a clinical study of men (mostly
white) aged 18-49 years who used it for 4 months.
Store at controlled room temperature 20° to 25° C (68° to 77° Fcontents under pressure. Do not puncture or incinerate container.Do not expose to heat or store at temperatures above 120°F(49°C)
Aqua, hyaluronic acid, cocamidopropyl betaine, keratin aminoacids, tocopherol(vitamin E), glycerol, xanthan gum, glyoxyloylallantoin, aloe barbadensis leaf extract, propylene glycol, vitasvinifera seed extract, polygonum cuspidatum extract,ethylhexlglycerin, biotin, argania spinosa kernel oil, simmondsiachinesis (jojoba) seed oil, castor oil, saw palmetto, peppermint oil.rosemary oil, pumpkin seed oil, caffeine, stinging nettle,niancinimide, green tea
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