Head and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Men

Manufacturer: The Procter & Gamble Manufacturing Company
Effective date: 2023-01-17
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 21:40:14

Label at a glance#

ProductHead and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Men

Active ingredientMINOXIDIL

Label structure11 sections

Dosage and administration

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.

Storage and handling

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 ab...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-723-9569

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/w (without propellant)

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for men

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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 SECTION

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 SECTION

Ask a doctor before use if you have heart disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

May be harmful if used when pregnant or breast-feeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

(1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

DIST. BY PROCTER & GAMBLE

CINCINNATI OH 45202.

PRINCIPAL DISPLAY PANEL - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Head and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Men
Minoxidil
BUTYLATED HYDROXYTOLUENE
BUTANE
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
ISOBUTANE
LACTIC ACID, UNSPECIFIED FORM
DEHYDRATED ALCOHOL
POLYSORBATE 60
PROPANE
STEARYL ALCOHOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69423-587	69423-587-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
BUTANE	6LV4FOR43R	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
ISOBUTANE	BXR49TP611	IACT
LACTIC ACID, UNSPECIFIED FORM	33X04XA5AT	IACT
MINOXIDIL	5965120SH1	ACTIB
DEHYDRATED ALCOHOL	3K9958V90M	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
PROPANE	T75W9911L6	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091344-001	MINOXIDIL	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2011-04-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f27b41f1-f63c-1c1c-e053-2a95a90a3518			cf5b888f-4362-4563-e053-2a95a90aeb6e	2023-01-17	Warnings	Exact identifier spl id: f27b41f1-f63c-1c1c-e053-2a95a90a3518 spl set id: cf5b888f-4362-4563-e053-2a95a90aeb6e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.