Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
Rdvhdlw 5% Minoxidil Hair Growth Foam With Biotin Aerosol, Foam
FDA Label NDC 85304-020
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 Borderless Technology Co., Ltd. for the product Rdvhdlw 5% Minoxidil Hair Growth Foam With Biotin (NDC 85304-020). 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 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 andlor texture.
It takes time to regrow hair. Results may occur at 3 months with twice a day usage. For some men, you may need to use 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 eves 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.
If you do not see hair regrowth in 6 months.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.lf swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222) right away.
Dosage & Administration
1.Hold the botle upside down and genly 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 application to 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.
Inactive Ingredient
cetyl alcohol
citric acid
glycerin
isobutane
lactic acid
polysorbate 60
purified water
SD alcohol 40-B
stearyl alcohol
butane
edetate disodium
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Label (Label)
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