FDA Label for Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men

Other

Drug Facts

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202.

Active Ingredients

Minoxidil 5% w/w (without propellant)

Purpose

Hair regrowth treatment for men

Use

• to regrow hair on the top of the scalp (vertex only, see picture 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.

Otc - Do Not Use

Do not use if

• ​​​you are a woman
• your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Aerosol, 5% (Foam) 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

Otc - Ask Doctor

Ask a doctor before use if you have heart disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking any other drugs

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
• it takes time to regrow hair. Results may occur at 2 months with twice a day useage. 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
• unwanted 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)

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 directions 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 Information

• hair growth has been shown in a clincial study of men (mostly white) aged 18-49 years who used it for 4 months
• see hair loss pictures on side of this carton
• before use, read all information on package and enclosed leaflet
• keep the package. It contains important information
• store at 20-25° C (68-77° F)
• contents under presure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120° F (49° C)

Inactive Ingredients

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, dehydrated alcohol. isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

1-800-723-9569

Principal Display Panel - Carton

Head & Shoulders

SCALP X

MINOXIDIL

TOPICAL AEROSOL, 5% (FOAM)

HAIR REGROWTH

TREATMENT

FOR MEN

CLINICALLY PROVEN TO HELP REGROW HAIR

Reactivates hair follicles to stimulate regrowth

Once-a-day foam for women

Six month supply

Unscented

3 CANS - 2.11 OZ (60 g) EACH

CARTON - CARTON