Otc - Active Ingredient
Minoxidil 5%
5%minoxidil Topical Aerosol(for Men) Aerosol, Foam
FDA Label NDC 84355-005
11 label sections · Submitted to the FDA by Guangzhou Binsi Clothing Co.,ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Binsi Clothing Co.,ltd. for the product 5%minoxidil Topical Aerosol(for Men) (NDC 84355-005). 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
Warnings
For external use only.
Otc - Do Not Use
on a broken or irritated scalp.
if you are allergic to any of the ingredients.
if you are pregnant or nursing, or have any underlying medical condition, consult a healthcare provider before use.
Otc - When Using
avoid contact with eyes. In case of contact, rinse thoroughly with water.
Otc - Stop Use
you experience headache, scalp redness,swelling, nausea, dizziness, or other adverse reactions.
Otc - Keep Out Of Reach Of Children
if swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Please note: When using an aerosol pump to
dispense foam, hold the bottle vertically upside down
and spray onto a smooth surface. Do not spray the
foam directly onto the scalp from an upright position.
Apply the foam to areas of hair loss on the scalp Gently massage with your fingertips for 3-5 minutes until fully absorbed.
using more product or applying it more
frequently will not improve results. Continued
use is required to help maintain hair regrowth;
otherwise, hair loss may resume.
Inactive Ingredient
AQUA
ALCOHOL
ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT
GLYCERIN
PROPANE
BUTANE
SODIUM PEG-7 OLIVE OIL CARBOXYLATE
TIPA-LAURETH SULFATE
SODIUM HYDROXIDE
POLYSORBATE 60
BIOTIN
CAFFEINE
NIACINAMIDE
CYCLODEXTRIN
Package Label.Principal Display Panel
Label1 (Label)
label
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