Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
5% Minoxidil Hair Growth Topical Solution Liquid
FDA Label NDC 87112-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yiwu Pu Feather Trading Co., Ltd for the product 5% Minoxidil Hair Growth Topical Solution (NDC 87112-002). 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
For Men and Women
Reduce hair loss
Restore thinning hair
Stimulate hair regrowth
Warnings
Keep out of reach of children.
For external use only.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away.
Otc - Do Not Use
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
May cause hair color/texture changes
Avoid eye contact. Rinse thoroughly with cool water if contact occurs.
Regrowth takes time. Results possible in 3 months (twice daily use); some need 6t months. Results vary.
Otc - Stop Use
·Chest pain, rapid heartbeat, faintness, or dizziness occurs.
·Sudden, unexplained weight gain occurs.
·If unwanted facial hair growth occurs.
·If you do not see hair regrowth in 6 months.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children,
Dosage & Administration
1. Open the cap,press to apply the solution onto target scalp areas.
2. Use twice daily.
3. Consistent use is required to maintain results; hair loss may recur if you stop using the product.
Inactive Ingredient
Butylene Glycol
Vitamin B5
Alcohol
Purified Water
Package Label.Principal Display Panel
Label (Label)
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