Active Ingredient
Minoxidil 2% w/v
The following Structured Product Label (SPL) was submitted to the FDA by Carol's Daughter, Llc for the product Minoxidil Topical Solution Usp, 2% (NDC 87532-001). 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 active ingredient, purpose, use, warnings, do not use if, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 2% w/v
Hair growth treatment
to regrow hair on the scalp
For external use only
Flammable: Keep away from flame
• 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
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. 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
• 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.
If swallowed, get medical help or contact a Poison Control Center right
away. (1-800-222-1222)
If swallowed, get medical help or contact a Poison Control Center right
away. (1-800-222-1222)
• 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. • in clinical studies of mostly white women aged 18–45 years with
mild to moderate degrees of hair loss, the following response to minoxidil topical
solution 2% was reported: 19% of women reported moderate regrowth after
using minoxidil topical solution 2% for 8 months (19% had moderate regrowth;
40% had minimal regrowth) this compares with 7% of women reporting
moderate hair regrowth after using the placebo, the liquid without minoxidil in it,
for 8 months (7% had moderate regrowth; 33% had minimal regrowth) • store
at 20° to 25°C (68° to 77°F). Keep tightly closed.
alcohol, propylene glycol, purified water
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