Other
5% Minoxidil Hair Regrowth Foam
5% Minoxidil Hair Regrowth Foam Aerosol, Foam
FDA Label NDC 85038-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lianjiang Shanlilai E-commerce Co., Ltd. for the product 5% Minoxidil Hair Regrowth Foam (NDC 85038-003). 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
Indications & Usage
Use to regrow hair on the top of the scalp
Warnings
For external use only. For use by men only.
Extremely Flammable:Avoid fire, flame, or smoking during andimmediately following application.
Otc - Do Not Use
you are a woman.
your amount of hair loss is different than that shown on side ofthis carton or your hair loss is on the front of the scalp.5% minoxidilfoam is not intended for frontal baldness or receding hairline.
You have no family history of hair loss.
Your hair loss is sudden andjor 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.
You use other medicines on the scalp.
Your scalp is red, inflamed, infected, irritated, or painful.
Otc - When Using
Do not apply on other parts of the body.
Avoid contact with the eyes. in case of accidental contact, rinseeyes with large amounts of cool tap water.
Some people have experienced changes in hair color and,;or textureit takes time to regrow hair, Results may occur at 3 months withtwice a day usage. For some men, you may need to use this productfor at least 6 months before you see results.
The amount of hair regrowth is different for each person.This product will not work for all men.
Otc - Stop Use
if chest pain, rapid heartbeat, faintness, or dizziness occurs.
if sudden, unexplained weight gain occurs.
if your hands or feet swell.
if scalp irritation or redness occurs.
if unwanted facial hair growth occurs.
if you do not see hair regrowth in 6 months.
Otc - Keep Out Of Reach Of Children
lf swallowed, get medical help or contact a Poison ControlCenter right away.(1-800-222-1222)right away.
Dosage & Administration
See enclosed leaflet for complete directions on how to use.
Apply half a capful twice daily directly to the scalp in the hair lossarea.
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 regrowthor hair loss will begin again.
Storage And Handling
Before use, read all information on carton and enclosed leaflet
Store at controlled room temperature 20° to 25°C (68° to 77°F).
Do not incinerate container. Do not expose to heat or store attemperature above 120°F(49°C).
Inactive Ingredient
ALCOHOL
GLYCERIN
CETYL ALCOHOL
STEARYL ALCOHOL
POLYSORBATE 80
ANHYDROUS CITRIC ACID
LACTIC ACID
CASTOR OIL
.ALPHA.-TOCOPHEROL
EDETATE DISODIUM
WATER
Package Label.Principal Display Panel
Label (Label1)
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