Drugplain

Leader Minoxidil 5 g/100mL

minoxidil · SOLUTION · Cardinal Health 110, LLC. dba Leader

No Recall History
Plain English

Leader Minoxidil is a solution containing minoxidil at 5 g/100mL, taken topical. Manufactured by Cardinal Health 110, LLC. dba Leader.

Key Facts

Brand Name
Leader Minoxidil
Generic Name
minoxidil
NDC Code (Product)
70000-0653
Manufacturer
Cardinal Health 110, LLC. dba Leader
Strength
5 g/100mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
ANDA075598
Drug Class
Arteriolar Vasodilator [EPC]
Marketing Start
03/04/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

adverse drug reaction8,500 reports
drug ineffective6,173 reports
application site pruritus2,521 reports
off label use1,425 reports
application site irritation1,212 reports
application site pain1,078 reports
headache1,061 reports
alopecia854 reports
application site dryness731 reports
inappropriate schedule of product administration728 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use to regrow hair on the scalp

Dosage & Administration

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 results • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Warnings

Warnings For external use only Flammable: Keep away from fire or flame Do not use if • your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you • you have no family history of hair loss • 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 Ask a doctor before use if you have heart disease When using this product • 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. You may need to use this product 2 times a day 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 everyone. Stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • sudden, unexplained weight

Frequently Asked Questions

What is Leader Minoxidil used for?

Leader Minoxidil contains minoxidil. It is a solution taken topical. Consult your doctor for specific uses.

Is Leader Minoxidil a controlled substance?

Leader Minoxidil is not classified as a controlled substance by the DEA.

What is the generic name for Leader Minoxidil?

The generic name for Leader Minoxidil is minoxidil. There are 12 other brand versions of minoxidil.

What is the NDC code for Leader Minoxidil 5 g/100mL?

The NDC (National Drug Code) for Leader Minoxidil 5 g/100mL is 70000-0653, listed by Cardinal Health 110, LLC. dba Leader.