Otc - Active Ingredient
Minoxidil 5%
5% Minoxidil Sprays Hair Egrowth Treatment Liquid
FDA Label NDC 87880-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tuosen Hong Kong Import Export Trading Co., Limited for the product 5% Minoxidil Sprays Hair Egrowth Treatment (NDC 87880-001). 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
Indications & Usage
Use to regrow hair on the scalp
Warnings
For external use only
Otc - Do Not Use
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. Do not use on babies and children.
your scalp is red inflamed, infected, imitated 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 amount 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 4 months with continuous usage.
The amount of hair regrowth is different for each person.This product will not work for everyone
Otc - Stop Use
your hands or feet swell
scalp imitation or redness occurs
your hands or feet swell
scalp imitation or redness occurs
unwanted facial hair growth occurs
you do not see hair regrowth in 4 months
Otc - Keep Out Of Reach Of Children
May be harmful if used when pregnant or breast-feeding, Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
apply one ml twice a day directly onto the scalp in the hair loss area for men
Using more or more often will not improve results
apply one ml twice a day directly onto the scalp in the hair loss area for women
Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Inactive Ingredient
Glycerin, Deionized Water.Biotin.Castor oil,Rosemary Oil, Panthenol, Niacinamide,Ethanol,Glycerin, Deionized Water.
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