Otc - Active Ingredient
Minoxidil 5%
Biotin 0.5%
5% Minoxidil Hair Growth Sprays Serum Liquid
FDA Label NDC 83766-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Joyuflsh Technology Co.,ltd. for the product 5% Minoxidil Hair Growth Sprays Serum (NDC 83766-003). 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 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
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 regr ow hair. Results may occur at 3 months wth 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 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
If unwanted facial hair growth occurs
If 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.Make sure your hair and scalp are dry(no need to wash your hair before each use)
2.Apply 3-4 pumps of spray directly to the treated area of the scalp
3.Gently massage into the scalp or thinning hair areas until absorbed.
4.Continued use is required to increase and maintain hair regrowth. Discontinuation 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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