Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
5% Minoxidil Hair Growth Topical Solution Liquid
FDA Label NDC 85304-018
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 5% Minoxidil Hair Growth Topical Solution (NDC 85304-018). 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 and beard.
Warnings
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
Avold contact with the eves. in case of accidental contact, rinse eves 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 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 diferent 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
Keep out of reach of children. f swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222)right away.
Dosage & Administration
1. After opening the cap, apply 1 ml by pressing and dotting onto the scalp area to be treated.
2. Gently massage the scalp or sparse hair area until fully absorbed.
3. Use twice daily.
4. Continuous use is necessary to increase and maintain har regrowth. Stopping use may lead to hair loss
Inactive Ingredient
Butylene Glycol
Glycerin
Alcohol
Castor oil
Dexpanthenol
Water
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Label (Label)
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