Minoxidil Topical Solution for Men

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil, USP 5% w/v

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for men

Use

INDICATIONS & USAGE SECTION

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

WARNINGS SECTION

For external use only. For use by men only.
Flammable: Keep away from fire or flame

Do not use if

OTC - DO NOT USE SECTION

• 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. Minoxidil topical solution 5% 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

OTC - ASK DOCTOR SECTION

heart disease

When using this product

OTC - WHEN USING SECTION

• 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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. 

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

OTHER SAFETY 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.
• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men
• In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
• store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (30% v/v), propylene glycol (50% v/v), purified water

Questions?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55301-094-73

Compare to the Active Ingredient in Men's Rogaine^® Extra Strength*

exchange select^™

EXTRA STRENGTH
FOR MEN
Minoxidil Topical
Solution, USP 5%
HAIR REGROWTH
TREATMENT

REACTIVATES HAIR FOLLICLES
TO STIMULATE REGROWTH

CLINICALLY PROVEN TO
HELP REGROW HAIR

UNSCENTED

NOT FOR USE BY WOMEN

FOR BEST RESULTS
APPLY DIRECTLY TO SCALP
TWICE DAILY

ONE MONTH SUPPLY
One 60 mL (2 fl oz) Bottle

quality value

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

• Minoxidil Extra Strength for Men
• Minoxidil
• ALCOHOL
• PROPYLENE GLYCOL
• WATER

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 140 matching rows.

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.