minoxidil

minoxidil
SPL v3
SPL
SPL Set ID 61c41686-81af-4000-94bc-3cf9e71b0f18
Route
topical
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
minoxidil (50 mg)
Inactive Ingredients
butylated hydroxytoluene cetyl alcohol anhydrous citric acid alcohol isobutane lactic acid, unspecified form butane polysorbate 60 propane water stearyl alcohol glycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
anda active Since 2025-08-28

Purpose

Hair regrowth treatment for men

Description

Minoxidil 5% w/w (without propellant)


Medication Information

Warnings

For external use only. For use by men only.

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

Purpose

Hair regrowth treatment for men

Directions
  • 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
  • hair growth has been shown in a clinical 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 carton and enclosed leaflet
  • keep the carton. It contains important information.
  • store at controlled room temperature 20° to 25°C (68° to 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, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40-B, stearyl alcohol

Description

Minoxidil 5% w/w (without propellant)

Principal Display Panel

Minoxidil Topical Aerosol 5% (For Men)

Hair Regrowth Treatment 

Easy-to Use Foam For Men

Not For Use by Women

Reactivates Hair Follicles

Unscented

Clinically Proven To Help Regrow Hair

Minoxidil Topical Aerosol, 5% is for men

who have a general thinning of hair on the

top of the scalp (vertex only, as shown

below). Not intended for frontal baldness or

a receding hairline. Minoxidil Topical

Aerosol, 5% (For Men) has been shown to

regrow hair in men with the following

degrees of thinning hair or hair loss.

For best results:

Use twice daily.

Apply directly to the scalp.

Read and keep carton and information leaflet for full product information.

Distributed by: BosleyMD

800.BOSLEY1 bosleymd.com

Manufactured for: Scientific Hair Research LLC,

Los Angeles, CA 90045

Questions?

Call 1-800-BOSLEY1 (1-800-267-5391)

Use

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

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
Package Label
Bosley Mens Hair Regrowth Treatment
Active Ingredient

Minoxidil 5% w/w (without propellant)

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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

heart disease.


Structured Label Content

Warnings

For external use only. For use by men only.

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

Purpose

Hair regrowth treatment for men

Directions
  • 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 (Other information)
  • hair growth has been shown in a clinical 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 carton and enclosed leaflet
  • keep the carton. It contains important information.
  • store at controlled room temperature 20° to 25°C (68° to 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 (Inactive ingredients)

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol 40-B, stearyl alcohol

Principal Display Panel (Principal display panel)

Minoxidil Topical Aerosol 5% (For Men)

Hair Regrowth Treatment 

Easy-to Use Foam For Men

Not For Use by Women

Reactivates Hair Follicles

Unscented

Clinically Proven To Help Regrow Hair

Minoxidil Topical Aerosol, 5% is for men

who have a general thinning of hair on the

top of the scalp (vertex only, as shown

below). Not intended for frontal baldness or

a receding hairline. Minoxidil Topical

Aerosol, 5% (For Men) has been shown to

regrow hair in men with the following

degrees of thinning hair or hair loss.

For best results:

Use twice daily.

Apply directly to the scalp.

Read and keep carton and information leaflet for full product information.

Distributed by: BosleyMD

800.BOSLEY1 bosleymd.com

Manufactured for: Scientific Hair Research LLC,

Los Angeles, CA 90045

Questions?

Call 1-800-BOSLEY1 (1-800-267-5391)

Use

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

Do Not Use If (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
Package Label (Package label)
Bosley Mens Hair Regrowth Treatment
Active Ingredient (Active ingredient)

Minoxidil 5% w/w (without propellant)

When Using This Product (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 (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
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease.


Advanced Ingredient Data


Raw Label Data

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