Men's Rogaine ®

Men's Rogaine ®
SPL v5
SPL
SPL Set ID ccaecec5-5348-4b24-9190-5464c50f6d80
Route
TOPICAL
Published
Effective Date 2023-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2010-07-16

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 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 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.

Flammable: Keep away from fire or flame

Directions
  • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
  • 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 800-764-2463 or 215-273-8755 (collect )
  • visit www.rogaine.com
Do Not Use If
  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution 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/v

Other Information
  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed booklet
  • keep the carton. It contains important information.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
  • In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
  • store at controlled room temperature 20º to 25º C (68º to 77º F)
Inactive Ingredients

alcohol, propylene glycol, purified water

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 Ml Bottle Carton

#1 DERMATOLOGIST



RECOMMENDED BRAND



MEN'S

Rogaine ®



EXTRA STRENGTH

5% Minoxidil



Topical Solution



Hair Regrowth Treatment



REACTIVATES



HAIR FOLLICLES



TO STIMULATE REGROWTH



Topical Solution

CLINICALLY PROVEN TO



HELP REGROW HAIR




UNSCENTED

Not For Use By Women

One Month Supply. One 60 mL (2 fl oz) Bottle


Structured Label Content

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of 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 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.

Flammable: Keep away from fire or flame

Directions
  • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
  • 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 800-764-2463 or 215-273-8755 (collect )
  • visit www.rogaine.com
Do Not Use If (Do not use if)
  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution 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/v

Other Information (Other information)
  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed booklet
  • keep the carton. It contains important information.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
  • In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
  • store at controlled room temperature 20º to 25º C (68º to 77º F)
Inactive Ingredients (Inactive ingredients)

alcohol, propylene glycol, purified water

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 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton)

#1 DERMATOLOGIST



RECOMMENDED BRAND



MEN'S

Rogaine ®



EXTRA STRENGTH

5% Minoxidil



Topical Solution



Hair Regrowth Treatment



REACTIVATES



HAIR FOLLICLES



TO STIMULATE REGROWTH



Topical Solution

CLINICALLY PROVEN TO



HELP REGROW HAIR




UNSCENTED

Not For Use By Women

One Month Supply. One 60 mL (2 fl oz) Bottle


Advanced Ingredient Data


Raw Label Data

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