Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
5% Minoxidil Hair Growth Foam Aerosol, Foam
FDA Label NDC 85304-019
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 Borderless Technology Co., Ltd. for the product 5% Minoxidil Hair Growth Foam (NDC 85304-019). 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 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 extemal 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 large amounts of cool tap water.
Some people have experienced changes in hair color and/or texture.
It takes ime to regrow hair, results may occur at2 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 diferent for each person. This product wil not work for all people.
Otc - Stop Use
Chest pain,rapid heartbeat faintness, or dizziness occurs.
Sudden,unexplained weight gain oceurs.
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. if swalowed, 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 hair loss will begin again.
Inactive Ingredient
cetyl alcohol
citric acid
glycerin
isobutane
lactic acid
polysorbate 60
purified water
SD alcohol 40-B
stearyl alcohol
butane
edetate disodium
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Label (Label)
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