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 Ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

Use

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

Warnings

For external use only.

Flammable: Keep away from fire or flame

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 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

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
• 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
• 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 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.
• hair regrowth has not been shown to last longer than 48 weeks in large clincial trials with continuous treatment with minoxidil topical solution 5% for men
• in clincial studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men proided more hair regrowth than minoxidil topical solution 2%
• store at 20-25° C (68-77° F). Keep tightly closed.

Inactive Ingredients

alcohol,propylene glycol, purified water

Questions Or Comments?

1-800-723-9569

Principal Display Panel - Carton

Head & Shoulders

SCALP X

MINOXIDIL

TOPICAL SOLUTION USP, 5%

HAIR REGROWTH

TREATMENT

FOR MEN

Extra Strength Topical Solution

CLINICALLY PROVEN TO HELP REGROW HAIR

Reactivates Hair Follicles to Stimulate Regrowth

Three month supply

Unscented

3 - 60 mL (2 FL OZ) BOTTLES

TOTAL 180 mL (6 FL OZ)

HS - HS