Head & Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men

Head & Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men
SPL v3
SPL
SPL Set ID f28f6336-1c3d-769b-e053-2a95a90a3deb
Route
TOPICAL
Published
Effective Date 2011-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Dehydrated Alcohol Water Propylene Glycol

Identifiers & Packaging

Marketing Status
ANDA Completed Since 2023-01-15 Until 2026-05-01

Description

Drug Facts

Purpose

Hair regrowth treatment for men


Medication Information

Purpose

Hair regrowth treatment for men

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

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

(1-800-222-1222)

Section 50566-9

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
Section 50567-7

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.
Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1

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
Section 53414-9

May be harmful if used when pregnant or breast-feeding

Warnings

For external use only.

Flammable: Keep away from fire or flame

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
Active Ingredient

Minoxidil 5% w/v

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)


Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

(1-800-222-1222)

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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.
Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)

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
Section 53414-9 (53414-9)

May be harmful if used when pregnant or breast-feeding

Purpose

Hair regrowth treatment for men

Warnings

For external use only.

Flammable: Keep away from fire or flame

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
Active Ingredient (Active ingredient)

Minoxidil 5% w/v

Other Information (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 (Inactive ingredients)

alcohol,propylene glycol, purified water

Questions Or Comments? (Questions or comments?)

1-800-723-9569

Principal Display Panel Carton (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)