HEAD AND SHOULDERS SCALP X MINOXIDIL HAIR REGROWTH TREATMENT FOR MEN- minoxidil solution

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

Ask a doctor before use if you have heart disease

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.

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

May be harmful if used when pregnant or breast-feeding

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

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202.

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)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS SCALP X MINOXIDIL HAIR REGROWTH TREATMENT FOR MEN 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-559
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-559-01	3 in 1 CARTON	01/15/2023
1		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091344	01/15/2023

Labeler - The Procter & Gamble Manufacturing Company (004238200)