Minoxidil

Minoxidil
SPL v3
SPL
SPL Set ID 5505e1b2-8c9b-457c-8291-cb8a9c1f6b10
Route
TOPICAL
Published
Effective Date 2022-10-04
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 2022-08-16

Description

Drug Facts

Purpose

Hair regrowth treatment for men


Medication Information

Purpose

Hair regrowth treatment for men

Description

Drug Facts

Use

to regrow hair on the top of the scalp (vertex only, 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 haveheart disease

Section 53414-9

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

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 1-866-923-4914
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

hair regrowth

treatment

for men

minoxidil topical aerosol, 5% (for men)

reactivates hair follicles to

stimulate regrowth

easy-to-use foam

unscented

not for use by women

up&up

FOAM

3

MONTH

SUPPLY

3 MONTH SUPPLY

THREE – 60 g (2.11 OZ) CANS


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)

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 haveheart 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.

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 1-866-923-4914
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)

hair regrowth

treatment

for men

minoxidil topical aerosol, 5% (for men)

reactivates hair follicles to

stimulate regrowth

easy-to-use foam

unscented

not for use by women

up&up

FOAM

3

MONTH

SUPPLY

3 MONTH SUPPLY

THREE – 60 g (2.11 OZ) CANS


Advanced Ingredient Data


Raw Label Data

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