WOMENS ROGAINE EXTRA STRENGTH - minoxidil solution
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

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Women's Rogaine 2%
Unscented Solution
Carton

Drug Facts

Active ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment

to regrow hair on the scalp

For external use only

Flammable: Keep away from fire or flame

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

Ask a doctor before use if you have heart disease

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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)

alcohol, propylene glycol, purified water

WOMEN'S
Rogaine®

2% MINOXIDIL
TOPICAL SOLUTION

HAIR REGROWTH
TREATMENT

UNSCENTED

CLINICALLY PROVEN
TO HELP REGROW HAIR

REACTIVATES HAIR FOLLICLES
TO STIMULATE REGROWTH

One Month Supply
1-60 mL (2 fl oz) Bottle

DERMATOLOGIST
#1
RECOMMENDED BRAND

WOMENS ROGAINE EXTRA STRENGTH
minoxidil solution

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Minoxidil (Minoxidil)	Minoxidil	20 mg in 1 mL

Packaging
#	NDC	Package Description	Multilevel Packaging
1	42002-105-02	1 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
1		60 mL In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (42002-105-02)
2	42002-105-06	3 BOTTLE In 1 CARTON	contains a BOTTLE, PLASTIC
2		60 mL In 1 BOTTLE, PLASTIC	This package is contained within the CARTON (42002-105-06)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019501	08/01/2010

Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 05/2011Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.