Active Ingredient
Minoxidil 5% w/w
5% Minoxidil Hair Growth Oil
FDA Label NDC 83462-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eubizrival Llc for the product 5% Minoxidil Hair Growth Oil (NDC 83462-005). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hair regrowth treatment
Use
to regrow hair on the scalp
Warnings
For external use only.
Do Not Use
You have no family history of hair loss. 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 it on babies and children.Scalp is red, inflamed, infected, irritated or painful.You use other medicines on the scalp.
When Using
Do not apply on other parts of the body. Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water. It takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results, The amount of hair regrowth is different for each person.The product will not work for everyone.
Stop Use
If scalp irritation or redness occurs. If you get unwanted facial hair growth. If you do not see hair regrowth in 4 months.If sudden, unexplained weight gain occurs.
Ask Doctor
If you have chest pain, rapid heart beat, faintness,
or dizziness occurs.
Keep Oot Of Reach Of Children
If swallowed, get medical help or contact
a poison control center right away.
Directions
. Apply 2-3 drops of serum directly to the
scalp in the area to be treated.
. Massage into the scalp with your fingers
then wash hands thoroughly.
- Using more hair regrowth serum or
using the serum more often will not
improve your results.
. Continued use is necessary to increase
and then maintain your hair regrowth.
. Discontinuing use may result in hair loss.
Other Information
Before use, read all information on the carton.
Keep the carton. It contains important
information.
Store at controlled room temperature 20
to 25℃ (68 to 77°F)
Contents under pressure. Do not
puncture or incinerate the container. Do
not expose to heat or store at
temperature above 120°F(49℃)
Inactive Ingredients
Inactive ingredients
water, biotin, dimethyl isosorbide,
acetic acid, panthenol, propylene glycol,
niacinamide, polysorbate 20
* Please review the disclaimer below.
