minoxidil

minoxidil
SPL v2
SPL
SPL Set ID c443fadd-669e-4d29-8b11-ef3c022ca6f4
Route
topical
Published
Effective Date 2022-10-25
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

Purpose

Hair regrowth treatment for women

Description

Drug Facts


Medication Information

Warnings

For external use only.

Purpose

Hair regrowth treatment for women

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
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

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

Description

Drug Facts

Questions?
  • Call 1-800-632-6900
Use

to regrow hair on the top of the scalp (see pictures on side of this 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 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.

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
Active Ingredient

Minoxidil 5% w/w (without propellant)

Extremely Flammable

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

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.
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
Principal Display Panel 60 G Can Carton

COMPARE TO

THE ACTIVE INGREDIENT

IN WOMEN'S ROGAINE®*

NDC 59450-211-02

Kroger®

*SEE SIDE

PANEL

#1 DERMATOLOGIST RECOMMENDED

ACTIVE INGREDIENT

ONCE-A-DAY FOAM

Minoxidil

Topical Aerosol, 5%

(For Women)

Hair Regrowth Treatment

CLINICALLY PROVEN

TO REGROW HAIR

REACTIVATES HAIR FOLLICLES

TO STIMULATE REGROWTH

UNSCENTED

FOUR MONTH SUPPLY

TWO 60 g (2.11 OZ) CANS

TOTAL 120 g (4.22 OZ)


Structured Label Content

Warnings

For external use only.

Purpose

Hair regrowth treatment for women

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
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)

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

Questions?
  • Call 1-800-632-6900
Use

to regrow hair on the top of the scalp (see pictures on side of this 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 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.

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
Active Ingredient (Active ingredient)

Minoxidil 5% w/w (without propellant)

Extremely Flammable

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

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

COMPARE TO

THE ACTIVE INGREDIENT

IN WOMEN'S ROGAINE®*

NDC 59450-211-02

Kroger®

*SEE SIDE

PANEL

#1 DERMATOLOGIST RECOMMENDED

ACTIVE INGREDIENT

ONCE-A-DAY FOAM

Minoxidil

Topical Aerosol, 5%

(For Women)

Hair Regrowth Treatment

CLINICALLY PROVEN

TO REGROW HAIR

REACTIVATES HAIR FOLLICLES

TO STIMULATE REGROWTH

UNSCENTED

FOUR MONTH SUPPLY

TWO 60 g (2.11 OZ) CANS

TOTAL 120 g (4.22 OZ)


Advanced Ingredient Data


Raw Label Data

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