Otc - Active Ingredient
Active ingredientMinoxidil 5% w/w (without propellant)
Purpose..Hair regrowth treatment for men
5%minoxidil Topical Foam Liquid
FDA Label NDC 87837-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veloce Trading Co., Limited for the product 5%minoxidil Topical Foam (NDC 87837-001). 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, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Warnings
ifYour hair loss is sudden andior patchy.
Your hair loss is associated with childbirth.
You do not know the reason for your hair loss.
Your scalp is red, inflamed, infected, irritated,or painful.
You use other medicines on the scalp.
You are under 18 years' of age.Do not use on babies and children.
Dosage & Administration
Use Twice Daily and enjoy thicker, fuller hair growth in as little as 3 to 6 months.
Indications & Usage
DIRECTIONS
1.Hold the bottle upside down and gently press the valve to dispense foam onto your handor a cold surface,approximately half a capful in size.2.Massage the foam into your scalp with your fingers, parting your hair into rows to ensureeven application to areas of thinning hair. Finally, wash your hands thoroughly.
Inactive Ingredient
INACTIVE INGREDIENTS
Propylene Glycol, Ethyl Alcohol, Phenoxyethanol, Amino Acid Surfactant, ButylatedHydroxytoluene (BHT), PEG-40 Hydrogenated Castor Oil, Ethylhexylglycerin
Package Label.Principal Display Panel
Labeling (87837 001 01)
Labeling (87837 001 01)
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