Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
Minoxidil 5% Topical Aerosol60g Aerosol, Foam
FDA Label NDC 83766-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Joyuflsh Technology Co.,ltd. for the product Minoxidil 5% Topical Aerosol60g (NDC 83766-005). 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 - stop use, otc - when using, 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
Use to regrow hair on the top of the scalp
Warnings
For external use only.
Extremely Flammable:Avoid fire, flame, or smoking during and immediately following application.
Otc - Do Not Use
Your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil foam is not intended for frontal baldness or receding hairline.
You have no family history of hair loss.
Your hair loss is sudden and/or patchy.
You do not know the reason for vour 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 - 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 - 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 cooltap water.
Some people have experienced changes in hair color and/or texture it takes time to regrow hair.Results may occur at 3 months with twice a day usage. For some people, you may need to use this product for 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 people.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center 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 loss area.
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 regrowth or hair loss will begin again.
Men:use twice daily.Women:use once daily.
Inactive Ingredient
Cetyl alcohol
Citric acid
Glycerin
Isobutane
Lactic acid
Polysorbate 60
Purified water
SD alcohol
Stearyl alcohol
Butane
Edetate disodium
Package Label.Principal Display Panel
Label (Label)
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