Otc - Active Ingredient
Minoxidil 5%
Biotin 0.2%
5% Minoxidil Hair Regrowth Serum With Biotin Liquid
FDA Label NDC 85304-027
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 Borderless Technology Co., Ltd. for the product 5% Minoxidil Hair Regrowth Serum With Biotin (NDC 85304-027). 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
Indications & Usage
Use to regrow hair of the scalp and beard growth for men
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 and/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.
Your scalp is red, inflamed, infected, irritated, or painful.
You use other medicines on the scalp.
Otc - When Using
Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water.
Otc - Stop Use
Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs
Scalp irritation or redness occurs.
Keep out of reach of children.
lf 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 3-6 drops Minoxidil Serum directly onto scalp on the hair loss area
Use fingertips to massage solution into skin/hair for 1 minutes then wash hands thoroughly.
Used once daily on clean dry hair for best results
Inactive Ingredient
Butylene Glycol
Glycerin
Alcohol
Panthenol
Water
Package Label.Principal Display Panel
Label1 (Label1)
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