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

Purpose

Hair regrowth treatment for men

Description

Drug Facts


Medication Information

Warnings

For external use only. For use by men only.

Purpose

Hair regrowth treatment for men

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
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).
Inactive Ingredients

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

Description

Drug Facts

Questions?
  • call toll-free 800-ROGAINE or 215-273-8755 (collect)
  • visit www.rogaine.com
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.

Active Ingredient

Minoxidil 5% w/w (without propellant)

Extremely Flammable

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

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

Warnings

For external use only. For use by men only.

Purpose

Hair regrowth treatment for men

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
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).
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

Questions?
  • call toll-free 800-ROGAINE or 215-273-8755 (collect)
  • visit www.rogaine.com
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.

Active Ingredient (Active ingredient)

Minoxidil 5% w/w (without propellant)

Extremely Flammable

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

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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