Minoxidil

Minoxidil
SPL v4
SPL
SPL Set ID ebda6e49-140c-4ab0-b155-5ed501ef3e8a
Route
TOPICAL
Published
Effective Date 2025-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Butane Butylated Hydroxytoluene Cetyl Alcohol Anhydrous Citric Acid Glycerin Isobutane Lactic Acid Polysorbate 60 Propane Water Alcohol Stearyl Alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2025-08-29

Description

Drug Facts

Purpose

Hair regrowth treatment for women


Medication Information

Purpose

Hair regrowth treatment for women

Description

Drug Facts

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.

Question?

Call 1-800-BOSLEY1 (1800-267-5391

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
Drug Facts

Drug Facts

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
Package Label
BOSLEY MD Hair regrowth treatment for women
Active Ingredient

Minoxidil 5% w/w (without propellant)

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 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 Women)

HAIR REGROWTH TREATMENT

CLINICALLY PROVEN TO HELP REGROW HAIR

Once-a-Day

Foam for Women

Reactivates

Hair Follicles

Unscented 

Read and keep carton and information leaflet for full product information

NOT FOR USE BY MEN

Distributed by: BosleyMD

800.BOSLEY1 bosleymd.com

©2024 Bosley, Inc. All rights reserved.

Manufactured for Scientific Hair Research LLC, 

Los Angeles, CA 90045

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 all women.
Pregnant Or Breast Feeding

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

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
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 (see pictures on side of this carton)

Purpose

Hair regrowth treatment for women

Warnings

For external use only.

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

Question?

Call 1-800-BOSLEY1 (1800-267-5391

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
Drug Facts

Drug Facts

Do Not Use If (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
Package Label (Package label)
BOSLEY MD Hair regrowth treatment for women
Active Ingredient (Active ingredient)

Minoxidil 5% w/w (without propellant)

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.
  • 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 Women)

HAIR REGROWTH TREATMENT

CLINICALLY PROVEN TO HELP REGROW HAIR

Once-a-Day

Foam for Women

Reactivates

Hair Follicles

Unscented 

Read and keep carton and information leaflet for full product information

NOT FOR USE BY MEN

Distributed by: BosleyMD

800.BOSLEY1 bosleymd.com

©2024 Bosley, Inc. All rights reserved.

Manufactured for Scientific Hair Research LLC, 

Los Angeles, CA 90045

When Using This Product (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 all women.
Pregnant Or Breast Feeding (Pregnant or breast-feeding)

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

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 6 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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