Otc - Active Ingredient
Minoxidil 5%
5% Minoxidil Hair Growth Serum Liquid
FDA Label NDC 84735-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hengyang Chuangjiujia Trading Co., Ltd. for the product 5% Minoxidil Hair Growth Serum Liquid (NDC 84735-012). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hair regrowth treatment
Indications & Usage
to regrow hair on the scalp
Warnings
For external use only.
Otc - Do Not Use
you have no family history of hair loss,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 notuse it on babies and children.scalp is red, inflamed, infected, irritated,or painful.
you use other medicines on the scalp
Otc - When Using
Do not apply on other parts ofthe body.
Avoid contact with eyes. in case ofaccidental contact, rinse eyes witha large amount of cool tap water.
lt takes time to regrow hair. You mayneed to use this product 2 times a day forat least 4 months before you see results The amount of hair regrowth is differentfor each person.
The product will not work for everyone.
Otc - Stop Use
chest pain, rapid heart beat, faintness,or dizziness occurs.
sudden, unexplained weight gain occurs.
your hands or feet swell.
scalp irritation or redness occurs.
you get unwanted facial hair growth.
you do not see hair regrowth in 4 months.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contacta poison control center right away.
Dosage & Administration
Apply 2-3 drops of serum directly to thescalp in the area to be treated.
Massage into the scalp with your fingersthen wash hands thoroughly.
Using more hair regrowth serum orusing the serum more often will notimprove your results.
Continued use is necessary to increaseand then maintain your hair regrowth.
Discontinuing use may result in hair loss.
Inactive Ingredient
Water
Biotin
Dimethyl isosorbide
Acetic acid
Panthenol
Propylene glycol
Niacinamide
Polysorbate 20
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