Minoxidil Topical Solution 2% Solution
FDA Label NDC 51672-2152

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Minoxidil Topical Solution 2% (NDC 51672-2152). 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, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Use

→ Warnings

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Package/label Principal Display Panel

Active Ingredient

Minoxidil USP 2% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on the scalp

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 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. (1-800-222-1222)

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

Other Information

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 to 45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution 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 controlled room temperature 20° to 25° C (68° to 77° F)