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

Description

Minoxidil 5% w/w (without propellant)

Purpose

Hair regrowth treatment for men


Medication Information

Purpose

Hair regrowth treatment for men

Description

Minoxidil 5% w/w (without propellant)

Use

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

Warnings

For external use only. For use by men only.

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

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
Questions?

Call 1-800-BOSLEY1 (1-800-267-5391)

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)

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

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

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

Use

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

Purpose

Hair regrowth treatment for men

Warnings

For external use only. For use by men only.

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

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
Questions?

Call 1-800-BOSLEY1 (1-800-267-5391)

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)

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

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.


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Raw Label Data

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