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5% Minoxidil Hair Growth Foam with Biotin
5% Minoxidil Hair Growth Foam With Biotin
FDA Label NDC 83988-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jinan Guyun Technology Co., Ltd for the product 5% Minoxidil Hair Growth Foam With Biotin (NDC 83988-003). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
Otc - Purpose
Hair Regrowth Treatment
Indications & Usage
USe to regrow hair of the scalp
Warnings
Flammable:keep away from fire or flame.
Keep out of reach of children.
For external use only.
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
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.
lt takes time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, you may need touse this product for at least 6 months before you see results. The amount of hair regrowth is different for each person.
Avoid contact with eyes, in case of accidental contact, rinse eyes with a large amount of cool tap water.
Otc - Stop Use
Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs.
lf unwanted facial hair growth occurs .
lf you do not see hair regrowth in 6 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
1.Hold the bottle upside down and gently press the valve to dispense foam onto your hand or 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 ensure even applicationto areas of thinning hair. Finally, wash your hands thoroughly.
3.Use Twice Daily and enjoy thicker, fuller hair growth in as little as 3 to 6 months.
Storage And Handling
Before use, read all information on the carton and the enclosed leaflet.
Store at a controlled room temperature of 20'C to 25°℃ (68'F to 77°F).
Do not incinerate the container. Do not expose it to heat or store it at temperatures above 40°C (104°F)
Inactive Ingredient
cetyl alcohol
citric acid
glycerin
isobutane
lactic acid
polysorbate 60
purified water
SD alcohol
stearyl alcohol
butane
edetate disodium
Package Label.Principal Display Panel
Label (2234)
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