Men's Rogaine® Unscented

Men's Rogaine® Unscented
SPL v7
SPL
SPL Set ID 1b5e2860-6855-4a65-8bbc-e064172a1adf
Route
TOPICAL
Published
Effective Date 2019-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
NDA Active Since 2010-10-01

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.

Section 50566-9

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
Section 50567-7

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.
Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1

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
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 booklet 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 toll-free 800-ROGAINE or 215-273-8755 (collect)
  • visit www.rogaine.com
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 package and enclosed booklet
  • keep the package. 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).
Extremely Flammable

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

Inactive Ingredients

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol40-B, stearyl alcohol

Principal Display Panel Three 60 G Can Package

#1 DERMATOLOGIST RECOMMENDED BRAND

MEN'S



Rogaine ®

5% MINOXIDIL TOPICAL AEROSOL



HAIR REGROWTH TREATMENT

REACTIVATES



HAIR FOLLICLES

TO STIMULATE REGROWTH

EASY-TO-USE



FOAM

CLINICALLY PROVEN TO HELP REGROW HAIR

UNSCENTED

Not For Use By Women

Three 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.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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.
Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)

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
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 booklet 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 toll-free 800-ROGAINE or 215-273-8755 (collect)
  • visit www.rogaine.com
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 package and enclosed booklet
  • keep the package. 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).
Extremely Flammable

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

Inactive Ingredients (Inactive ingredients)

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol40-B, stearyl alcohol

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

#1 DERMATOLOGIST RECOMMENDED BRAND

MEN'S



Rogaine ®

5% MINOXIDIL TOPICAL AEROSOL



HAIR REGROWTH TREATMENT

REACTIVATES



HAIR FOLLICLES

TO STIMULATE REGROWTH

EASY-TO-USE



FOAM

CLINICALLY PROVEN TO HELP REGROW HAIR

UNSCENTED

Not For Use By Women

Three Month Supply • Three 60 g (2.11 oz) Cans


Advanced Ingredient Data


Raw Label Data

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