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 Finally Hair Minoxidil 5% Hair Growth Foam (NDC 81653-011). 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 people
to regrow hair on the top of the scalp
For external use only. Avoid getting product in your eyes or mouth. If contact occurs, rinse with water and consultant a doctor. Keep out of reach of children. Do not apply on broken or irritated skin.
■ you are a pregnant woman
■ 5% minoxidil topical solution 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 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 2 months with twice a day usage. For some people, 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 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.
heart disease
Yes, Keep Oot Of Reach Of Children
■ apply right amount 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.
For best results: Keep using (Men use twice a daily. Women use once a day).
■ see hair loss pictures on side of this carton
■ before use, read all information on carton
■ keep the carton. It contains important information.
■ hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Hair Regrowth Treatment for men and women
■ In clinical studies with mostly white men and women aged 18-49 years with moderate degrees of hair loss, Hair Regrowth Treatment for people provided more hair regrowth than minoxidil topical solution 2%
■ store at 20° to 25°C (68° to 77°F). Keep tightly closed.
Aqua, Biotin, EDTA ,Methylparaben, Allantoin, Adenosine, Niacinamide, Water Soluble Azone, Phenoxyethanol, Propylene Glycol, Collagen
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