Minoxidil

Minoxidil
SPL v2
SPL
SPL Set ID 8346788b-88b3-45c6-8c27-b34a810154fb
Route
TOPICAL
Published
Effective Date 2022-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2022-10-18

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)

Section 42229-5

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

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 50569-3

Ask a doctor before use if you have heart disease

Section 53414-9

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

Warnings

For external use only.

For use by men only.

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 1-800-632-6900
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. 5% minoxidil topical 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
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

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

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
Principal Display Panel 60 G Can Carton

COMPARE TO

THE ACTIVE INGREDIENT

IN MEN'S ROGAINE®*

NDC 59450-210-01

Kroger®

*SEE SIDE

PANEL

#1 DERMATOLOGIST RECOMMENDED

ACTIVE INGREDIENT

EASY-TO-USE FOAM

Minoxidil

Topical Aerosol, 5%

(For Men)

Hair Regrowth

Treatment

CLINICALLY

PROVEN TO

HELP REGROW

HAIR

REACTIVATES

HAIR FOLLICLES

TO STIMULATE REGROWTH

UNSCENTED

NOT FOR USE BY WOMEN

ONE MONTH SUPPLY

One 60 g (2.11 oz) Can


Structured Label Content

Use

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

Section 42229-5 (42229-5)

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

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 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

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.

For use by men only.

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 1-800-632-6900
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. 5% minoxidil topical 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
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)

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

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
Principal Display Panel 60 G Can Carton (PRINCIPAL DISPLAY PANEL - 60 g Can Carton)

COMPARE TO

THE ACTIVE INGREDIENT

IN MEN'S ROGAINE®*

NDC 59450-210-01

Kroger®

*SEE SIDE

PANEL

#1 DERMATOLOGIST RECOMMENDED

ACTIVE INGREDIENT

EASY-TO-USE FOAM

Minoxidil

Topical Aerosol, 5%

(For Men)

Hair Regrowth

Treatment

CLINICALLY

PROVEN TO

HELP REGROW

HAIR

REACTIVATES

HAIR FOLLICLES

TO STIMULATE REGROWTH

UNSCENTED

NOT FOR USE BY WOMEN

ONE MONTH SUPPLY

One 60 g (2.11 oz) Can


Advanced Ingredient Data


Raw Label Data

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