Otc - Active Ingredient
Minoxidil 5% w/v
The following Structured Product Label (SPL) was submitted to the FDA by Mdalgorithms, Inc for the product Mdhair Extra Strength Hair Regrowth Treatment For Men (NDC 71804-704). 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, use, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5% w/v
Hair regrowth treatment for men
to regrow hair on the top of the scalp (vertex only, see picture on side of carton)
For external use only. For use by men only.
Flammable: Keep away from fire or flame
• 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. 5% minoxidil topical solution 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, irritated or painful • you use other medicines on the scalp
Ask a doctor before use if you have heart disease
• do not apply on other parts of the body • 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 regrow hair. 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 for all men.
May be harmful if used when pregnant or breast-feeding.
If swallowed, get medical help or contact a Poison Control Center right away.
• 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 results • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
• see hair loss pictures on side of this carton
• before use, read all information on carton and enclosed leaflet • keep the carton. It contains important information. • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
• store at controlled room temperature 20° to 25°C (68° to 77°F).
Alcohol, Propylene Glycol, Purified Water
Call MDalgorithms Inc. at; 1-833-257-1914
or contact us at; [email protected]
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