Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
5% Minoxidil Hair Regrowth Serum With Biotin Liquid
FDA Label NDC 85038-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lianjiang Shanlilai E-commerce Co., Ltd. for the product 5% Minoxidil Hair Regrowth Serum With Biotin (NDC 85038-008). 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 and promote 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.
You need to use this product once a day for best results.The amount of hairreg rowth varies for each person.
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 you get unwanted facial hair growth occurs.
If you do not see hair regrowth in 4 months.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away.
Dosage & Administration
Apply 3-6 drops Minoxidil Serum directly onto scalp on the hair loss area, (3-4 drops for women, 5-6 drops for men)
Massage with your hands for 1 minute. After massaging, wash your hands thoroughly.
Used once daily on clean dry hair for best results.
Inactive Ingredient
Alcohol
Panthenol
Glycerin
Anhydrous citric acid
Polysorbate 60
Carbomer homopolymer
Water
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