Other
5% Minoxidil Hair Growth Foam with Biotin
5% Minoxidil Hair Growth Foam With Biotin
FDA Label NDC 83988-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jinan Guyun Technology Co., Ltd for the product 5% Minoxidil Hair Growth Foam With Biotin (NDC 83988-002). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
Otc - Purpose
Hair regrowth treatment for men and women
Indications & Usage
Use to regrow hair of the scalp
Warnings
Flammable: keep away from fire or flame.
Keep out of reach of children.
For external use only
Otc - Do Not Use
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.
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 largeamounts 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 davusage, for some people, you may need to use this product for at least 4months before you see results.
The amount of hair regrowth is different for each person. This product willnot 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,
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact
a Poison Control Center(1-800-222-1222)right away.
Dosage & Administration
Apply half a capful 2 times a day to the scalp in the hair loss area.
Massage into scalp with fingers, then wash hands well.
See enclosed leaflet for complete directions on how to use.
Using more or more often will not improve results.
Continued use is necessary to increase and keep your hair regrowth or hairloss will begin again.
Storage And Handling
Before use, read all information on carton and enclosed leaflet.Store at controlled room temperature 20° to 25°℃ (68° to 77°F)Do not incinerate container. Do not expose to heat or store at temperatureabove 104°F(40°C)
Inactive Ingredient
ALCOHOL
GLYCERIN
CETYL ALCOHOL
STEARYL ALCOHOL
POLYSORBATE 80
ANHYDROUS CITRIC ACID
LACTIC ACID
CASTOR OIL
EDETATE DISODIUM
ISOBUTANE
BUTANE
WATER
Package Label.Principal Display Panel
Label (2)
Label2 (4)
Label6 (6)
* Please review the disclaimer below.
