H
minoxidil
Dosage Form: topical solution
CVS Pharmacy, Inc. Hair Regrowth Treatment for Women Drug Facts
Active ingredient
Minoxidil 2% w/v
Purpose
Hair regrowth treatment
Uses
to regrow hair on the scalp
Warnings
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
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
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.
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
Other information
see hair loss pictures on side of this carton
before use, read all information on carton and enclosed leaflet
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 minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% 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 20° to 25°C (68° to 77°F). Keep tightly closed.
Inactive ingredients
alcohol, propylene glycol, purified water
Questions or comments?
1-800-719-9260
Principal Display Panel
Hair Regrowth Treatment for Women
Minoxidil Topical Solution USP 2%
Hair Regrowth Treatment
Clinically Proven to Help Regrow Hair
Revitalizes Hair Follicles
Unscented
Compare to Women’s Rogaine® active ingredient
# Month Supply
Hair Regrowth Treatment for Women Carton - Left Side
Hair Regrowth Treatment for Women Carton - Right Side
Hair Regrowth Treatment for Women
minoxidil solution
Product Information
Product Type
HUMAN OTC DRUG
NDC Product Code (Source)
59779-856
Route of Administration
TOPICAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
MINOXIDIL (MINOXIDIL)
MINOXIDIL
2 g in 100 mL
Inactive Ingredients
Ingredient Name
Strength
No Inactive Ingredients Found
Product Characteristics
Color
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
59779-856-16
1 BOTTLE In 1 CARTON
contains a BOTTLE
1
60 mL In 1 BOTTLE
This package is contained within the CARTON (59779-856-16)
2
59779-856-30
3 BOTTLE In 1 CARTON
contains a BOTTLE
2
60 mL In 1 BOTTLE
This package is contained within the CARTON (59779-856-30)
3
59779-856-34
4 BOTTLE In 1 CARTON
contains a BOTTLE
3
60 mL In 1 BOTTLE
This package is contained within the CARTON (59779-856-34)
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA075357
09/08/2006
Labeler - CVS Pharmacy (062312574)
Revised: 07/2009CVS Pharmacy
More Hair Regrowth Treatment for Women resources
Hair Regrowth Treatment for Women Side Effects (in more detail)Hair Regrowth Treatment for Women Use in Pregnancy & BreastfeedingHair Regrowth Treatment for Women Drug Interactions0 Reviews for Hair Regrowth Treatment for Women - Add your own review/rating
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