Women's Rogaine ®

Women's Rogaine ®
SPL v4
SPL
SPL Set ID 8bf0000c-95f3-4a4d-830b-f5ac1539823d
Route
TOPICAL
Published
Effective Date 2023-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (20 mg)
Inactive Ingredients
Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2010-08-01

Description

Drug Facts

Purpose

Hair regrowth treatment


Medication Information

Purpose

Hair regrowth treatment

Description

Drug Facts

Use

to regrow hair on the scalp

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

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
  • your degree of hair loss is different than that shown on the 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 2% 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.
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • store at controlled room temperature 20° to 25° C (68° to 77° 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. You may need to use this product 2 times a day 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 everyone.
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

WOMEN’S

Rogaine ®

2% Minoxidil

Topical Solution

Hair Regrowth

Treatment

REACTIVATES

HAIR FOLLICLES

TO STIMULATE

REGROWTH

CLINICALLY PROVEN

TO HELP REGROW HAIR

Topical Solution

UNSCENTED

One Month Supply

One 60 mL (2 fl oz) Bottle


Structured Label Content

Use

to regrow hair on the scalp

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

Warnings

For external use 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)
  • your degree of hair loss is different than that shown on the 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 2% 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.
  • In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • store at controlled room temperature 20° to 25° C (68° to 77° 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. You may need to use this product 2 times a day 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 everyone.
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

WOMEN’S

Rogaine ®

2% Minoxidil

Topical Solution

Hair Regrowth

Treatment

REACTIVATES

HAIR FOLLICLES

TO STIMULATE

REGROWTH

CLINICALLY PROVEN

TO HELP REGROW HAIR

Topical Solution

UNSCENTED

One Month Supply

One 60 mL (2 fl oz) Bottle


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)