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 5% w/w (without propellant)

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for women

Use

INDICATIONS & USAGE SECTION

to regrow hair on the top of the scalp (see pictures on side of this carton)

Warnings

WARNINGS SECTION

For external use only.
Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

Do not use if

OTC - DO NOT USE SECTION

• 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 

OTC - ASK DOCTOR SECTION

heart disease

When using this product

OTC - WHEN USING SECTION

• do not use more than directed
• 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 3 months with once daily use For some women, you may need to use this product once a day for at least 6 months before you see results.
• the amount of hair regrowth is different for each person. This product will not work for all women.

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 6 months

May be harmful if used when pregnant or breast-feeding.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• see enclosed leaflet for complete directions on how to use
• apply half a capful once daily directly to the scalp in the hair loss area
• massage into scalp with fingers, then wash hands well
• 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.
• store at controlled room temperature 20º to 25ºC (68º to 77ºF)
• contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperature above 120ºF (49ºC).

Inactive ingredients

INACTIVE INGREDIENT SECTION

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40-B, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-888-237-4131

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to active ingredient in Women's Rogaine®

Minoxidil

Topical Aerosol, 5%

Hair Regrowth Treatment For Women

Clinically proven to help regrow hair

Reactivates hair follicles to stimulate regrowth

Unscented

Once-a Day

Foam for women

TWO MONTH SUPPLY

60 g (2.11OZ CAN

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Women's Rogaine®.

Distributed by:

Profectus Beauty, LLC.,

111 Town Square Pl, Suite 1130

Jersey City, NJ 07310

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

• Minoxidil
• BUTANE
• BUTYLATED HYDROXYTOLUENE
• CETYL ALCOHOL
• ANHYDROUS CITRIC ACID
• GLYCERIN
• ISOBUTANE
• LACTIC ACID
• POLYSORBATE 60
• PROPANE
• WATER
• ALCOHOL
• STEARYL ALCOHOL

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Orange Book application contexts#

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

Orange Book products#

Current product rows page 1 of 1 · 2 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 3 · 88 observed states.

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Reported adverse events (FAERS/openFDA)#

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