Active Ingredient(S)
Minoxidil 5% w/v
5% Minoxidil Serum Liquid
FDA Label NDC 84558-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yusong Fine Chemicls Co., Ltd for the product 5% Minoxidil Serum (NDC 84558-031). 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(s), purpose, use, warnings, 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
Purpose
Hair Regrowth Treatment
Use
Use to regrow hair on the vertex (top of
scalp) in men with androgenetic alopecia.
Warnings
For external use only.
Do Not Use
▪ you are a woman
▪ your hair loss pattern is different from the examples 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
Ask a doctor before use if you have heart disease.
Otc - When Using
▪ 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.
Otc - Stop Use
▪ 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
▪ If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away at
1-800-222-1222.
Directions
Apply 1 mL twice a day directly onto the
scalp in the hair loss area for men only.
Using more or more often will not improve
results. Loss will begin again if use is
stopped. Continued use is necessary to
increase and keep your hair regrowth, or
hair loss will begin again.
Other Information
Store at 20-25°C (68-77°F). Keep tightly closed.
Before use, read all information on carton. Keep the carton. It contains important information.
Inactive Ingredients
Water, Propylene Glycol, Glycerin,
Butanediol, Glycine, Xanthan Gum,
PEG-40 Hydrogenated Castor Oil.
Package Label - Principal Display Panel
label
Undefined (Label)
* Please review the disclaimer below.
