Otc - Active Ingredient
Minoxidil 5% w/w (without propellant)
Diaminopyrimidine oxide 3%
Minoxidil Hair Growth Foam
FDA Label NDC 84315-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yibai Technology Sarl for the product Minoxidil Hair Growth Foam (NDC 84315-001). 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, 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
Treat hair loss caused by premature loss of hair roots
Indications & Usage
Treatment of hair loss and alopecia areata
Warnings
For external use only.
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.
Otc - Do Not Use
You are allergic to any of the ingredients
You have no family history of hair loss.
Your hair loss is sudden and/or patchy.
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.
Ask a doctor before use if you have heart disease
Otc - When Using
Do not apply on other parts of the body.
Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
Some people have experienced changes in hair color and/or texture.
It takes time to regrow hair, Results may occur at 2 months with twice a day usage.For some one, you may need to use this product for at least 4 months before you see results.The amount of hair regrowth is different for each person. This product will notwork for all.
Otc - Stop Use
Stop use and ask a doctor if
Chest pain, rapid heartbeat,faintness,or dizziness occurs.
Sudden, unexplained weight gain occurs.
Your hands or feet swell.
Scalp irritation or redness occurs.
Unwanted facial hair growth occurs.
You do not see hair regrowth in 4 months.
Otc - Keep Out Of Reach Of Children
May be harmful if used when pregnant or breast-feeding.
Keep out of reach of children. if swallowed,get medical help or contact a Poison Control Center right away(1-800-222-1222)
Dosage & Administration
Apply evenly to hair loss areas twice a day and massage scalp for 1-2 minutes until absorbed,then wash hands well.See enclosed leaflet for complete directions how to use.Using more or more often will not improve results.Continued use is necessary to increase and keep your hair regrowth or hair loss will begin again
Storage And Handling
Store at controlled room temperature 20° to 25℃ (68° to 77°F) Contents under pressure.
Do not puncture or incinerate container.
Do not expose to heat or store at temperatures above 120°F (49℃)
Inactive Ingredient
1.2-propylene glycol 37%, ethanol 25%, water 30%
Package Label.Principal Display Panel
84315-001-01 (84315 001 01)
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