Otc - Active Ingredient
Minoxidil 5% w/v
The following Structured Product Label (SPL) was submitted to the FDA by Rize Health, Llc for the product Rize Hair Regrowth Treatment For Men 5% (NDC 73630-001). 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
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
For external use only
Flammable: Keep away from fire or flame
Do not use if
■ you are a woman
■ your amount of hair loss is dierent 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
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. 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 everyone.
■ chest pain, rapid heartbeat, faintness, or dizziness occurs
■ sudden, unexplained weight gain occurs
■ your hands or feet swell
■ scalp irritation or redness occurs
■ unwanted facial hair growth occurs
■ you do not see hair regrowth in 4 months
May be harmful if used when pregnant or breast-feeding.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
alcohol, propylene glycol, purified water
* Please review the disclaimer below.