Active Ingredient(S)
Minoxidil 5%
Hair Regen Hair Regrowth Treatment Liquid
FDA Label NDC 84232-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yiwu�yizhou�trading�co.,ltd for the product Hair Regen Hair Regrowth Treatment (NDC 84232-002). 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 active ingredient(s), purpose, use, warnings, do not use, when using this product., 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
Purpose
HAIR REGROWTH TREATMENT
Use
USE to regrow hair on top of scalp (vertex only, see pictures on side of box)
Warnings
For external use only. For use by men only.
Do Not Use
- You are a woman.
- Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
- 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, rritated, or painful.
- You use other medicines on the scalp.
When Using This Product.
●Do not apply on other parts of your body.
●Avoid contact with the eyes. In case 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 hai, results may occur at 2 months with twice a day usage. For some men, 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 not work on all men,
Stop Use
●Chest pain, rapid heartbeat, faintness, or dizziness occurs
●Sudden, unexplained weight gain occurs
●Your hands or feet swell
●Scalp rritation or redness ocurs
●Unwanted facial hair growth occurs
●You do not see hair growth in 4 months
Otc - Keep Out Of Reach Of Children
Keep away from fire or flame
Directions
●Apply one mL. with dropper 2 times a day directly onto the scalp in the hair loss area.
●Using more or more often will not improve resufts.
●continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
Other Information
●See hair loss pictures on side of box
●Before use, read all information on box and enclosed instructions.
●Keep the box, it contains important information.
●Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical sol ution 5% for men.
●In Clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical sol lution 2%
●Store at 20° to 25*C (68° to 77*F). Keep tightly closed
Inactive Ingredients
alcohol, propylene glycol, purified water
Package Label - Principal Display Panel
Undefined (Label)
Undefined (Label1)
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