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 Growplex Vitafoam (NDC 81653-016). 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, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5% w/v
Hair regrowth treatment for women
to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
For external use only. For use by women only.
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.
- you are a man
- your hair loss is different than that shown on the carton
- 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
- your scalp is red, inflamed, infected, irritated, or painful
- you use other medicines on the scalp
- 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 4 months with once-daily use. For some women, you may need to use the 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 women
- 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.
- 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.
If swallowed, get medical help or contact a Poison Control Center right away.
- apply 2 to 3 pumps of foam once a day 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 may be necessary to maintain hair regrowth, or hair loss will begin again
- store at controlled room temperature 20° to 25°C (68° to 77°F)
- do not expose to heat or store at temperature above 49°C (120°F)
Alcohol, Angelica Sinensis, Arctium Lappa L, Biotin, Cacumen Platycladi Orientalis P.E., Capsaicin, PEG-40 Hydrogenated Castor Oil, Carthamus Tinctorius L Extract, Cortex Dictamni, Fructus Ligustri Lucidi Extract, Ginger Extract, Ginseng Extract, Glycyrrhiza Uralensis Fisch Extract, Ligusticum Chuanxiong Hort Extract, Polygonum Multiflorum Thunb, Water.
81653-016-01
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