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

Head and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Women by

Drug Labeling and Warnings

Head and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Women by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment for women

Use

to regrow hair on the top of the scalp

Warnings

For external use only.

Flammable: Keep away from fire or flame

Do not use if

• your degree of hair loss is different than that shown on 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 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. You may need to use this product 2 times a day 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 allwomen.

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 6 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.
• store at 20-25° C (68-77° F)
• contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Inactive ingredients

alcohol,propylene glycol, purified water

Questions or comments?

1-800-723-9569

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DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202.

PRINCIPAL DISPLAY PANEL - Carton

Head & Shoulders

SCALP X

MINOXIDIL

TOPICAL SOLUTION USP, 2%

HAIR REGROWTH

TREATMENT

FOR WOMEN

CLINICALLY PROVEN TO HELP REGROW HAIR

Reactivates hair follicles to stimulate regrowth

Topical Solution

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 WOMEN 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-558
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	2 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: 69423-558-01	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)