FDA Label for 5% Minoxidil Topical Solution

Otc - Active Ingredient

​Drug Facts

​Active Ingredient

Minoxidil 5% w/w (without propellant)

​Purpose

Hair regrowth treatment for men

​Use

To regrwo hair on the top of the scalp (vertex only, see pictures on side of this carton)

​Warnings

For external use only.

For use by men only.

​​Extremely Flammable:​ Avoid fire, flame, or smoking during and immediately following application.

​Do Not Use If

• you are a woman
• your amount of hair loss is different than taht shown on side of this carton or your
• hair loss is on the front of the scalp 5% minoxidil topical foam is not intended for
• frontal baldmess 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

Otc - Ask Doctor

​Ask a doctor before use if you have heart disease

Otc - When Using

​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
• 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.

Otc - Stop Use

​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
• unwated facial hair growth occurs
• you do not see hair regrowth in 4 months

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

​Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Dosage & Administration

​Directions

• ​apply half a capful 2 times a day to the scalp in the hair loss area
• massage into scalp with fingers, then wash hands well
• see enclosed leaflet for complete directons on how to use
• 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 Safety Information

​Other information​

• hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
• see hair loss picture 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 20° to 25°C (68° to 77°F)
• contents under pressure. Do not puncture or incinerate container.
• do not expose to heat or store at temperature above 120°F (49°C).

Inactive Ingredient

​Inactive ingredients

​butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate-60, propane, purified water, stearyl alcohol

Otc - Questions

​Questions?

• ​Call ​1-470-737-9424

Manufactured and distributed by:

Gabar Health Sciences Corp., Atlanta, GA 30385

​Principal Display Panel - 60 G Can Carton Keeps

​Minoxidil Topical Aerosol, 5% (For Men)

HAIR REGROWTH TREATMENT

​Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

#1 Dermatologist Recommended Active Ingredient

Easy-to-use-foam unscented

​THREE MONTH SUPPLY

​THREE 60 g (2.11 OZ) CANS

​NOT FOR USE BY WOMEN

Minoxidil Men Carton Label - minoxidil men carton