Otc - Active Ingredient
Minoxidil 5%
Minoxidil Hair Regrowth Kit Liquid
FDA Label NDC 87813-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Zeus E-commerce Co., Ltd for the product Minoxidil Hair Regrowth Kit (NDC 87813-001). 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 for men
Indications & Usage
Use to regrow hair of scalp and beard
Warnings
For external use only.
Keep out of reach of children.
Otc - Do Not Use
You have no family history of hair loss.
Your hair loss is sudden or patchy.
Your hair loss is associated with childbirth.
You do not know the reason for your hair loss.
You are under 18 years of age.Do not use on babies and children.
Our scalp is red, inflamed, infected, or painful.
You use other medicines on the scalp.
Otc - When Using
Ask doctor before use if you have heart disease.
Avoid contact with eyes. In case of accidental contact,rinse eyes with a large amount of cool tap water.
Otc - 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.
·If swallowed, get medical help or contact a poison control center(1-800-222-1222)right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Apply the roll-on solution directly tothe clean and dry scalp in thehair loss area. Roll evenly over thedesired area 4-5 times, then gentlymassage with fingertips for2-3 minutes to help absorption.Do not rinse.Use 1-2 times daily.Allow the scalp to dry completelybefore applying any otherhair products. Wash hands thoroughlyafter use. Do not exceed 2 mL per day.Continued use for several months isnecessary to help increase andmaintain hair regrowth.
Inactive Ingredient
AQUA
DIPROPYLENE GLYCOL
DISODIUM EDTA
ALCOHOL
PROPYLENE GLYCOL
BUTYLENE GLYCOL
NIACINAMIDE
BIOTIN
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
ALOE BARBADENSIS LEAF JUICE
Package Label.Principal Display Panel
Label (Label)
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