Head & Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Women

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]

HEAD AND SHOULDERS SCALP X MINOXIDIL HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil aerosol, foam 
The Procter & Gamble Manufacturing Company

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Head & Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Women

Drug Facts

Active ingredient

Minoxidil 5% w/w (without propellant)

Purpose

Hair regrowth treatment for women

Use

to regrow hair on the top of the scalp (see pictures on side of this carton)

Warnings

For external use only.

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

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 use more than directed
• 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 3 months with once-daily use. For some women, you may need to use this product once a day for at least 6 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

• see enclosed leaflet for complete directions on how to use
• apply half a capful once daily directly to the scalp in the hair loss area
• massage into scalp with fingers, then wash hands well
• 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

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

Questions?

1-800-723-9569

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202.

PRINCIPAL DISPLAY PANEL - Carton

Head & Shoulders

SCALP X

MINOXIDIL

TOPICAL AEROSOL, 5% (FOAM)

HAIR REGROWTH

TREATMENT

FOR WOMEN

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

HEAD AND SHOULDERS SCALP X MINOXIDIL HAIR REGROWTH TREATMENT FOR WOMEN 
minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-586
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 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTANE (UNII: 6LV4FOR43R)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ISOBUTANE (UNII: BXR49TP611)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPANE (UNII: T75W9911L6)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-586-01	3 in 1 CARTON	11/01/2021	12/15/2024
1		60 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091344	11/01/2021	12/15/2024

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 1/2023

Document Id: f290326b-c489-2380-e053-2a95a90a88e1

34390-5

Set id: ce556448-8634-78fa-e053-2995a90ad407

Version: 5

Effective Time: 20230118

 

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