C
Generic Name: minoxidil
Dosage Form: solution
American Sales Company Hair Regrowth Treatment for Men Drug Facts
Active ingredient
Minoxidil 5% w/v
Purpose
Hair regrowth treatment for men
Uses
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
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. Minoxidil topical solution 5% 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
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. 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
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.
hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men
in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
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
Compare to the active ingredient in Men’s Rogaine® Extra Strength
Extra Strength
Minoxidil Topical Solution USP, 5%
Hair Regrowth Treatment
For Men
Clinically Proven to Help Regrow Hair
Revitalizes Hair Follicles
Unscented
Not for Use by Women
# Month Supply
Hair Regrowth Treatment for Men Carton
CAREONE HAIR REGROWTH TREATMENT EXTRA STRENGTH
minoxidil solution
Product Information
Product Type
HUMAN OTC DRUG
NDC Product Code (Source)
41520-798
Route of Administration
TOPICAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
MINOXIDIL (MINOXIDIL)
MINOXIDIL
3 g in 60 mL
Inactive Ingredients
Ingredient Name
Strength
No Inactive Ingredients Found
Product Characteristics
Color
YELLOW (Light Amber)
Score
Shape
Size
Flavor
Imprint Code
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
41520-798-16
1 BOTTLE In 1 CARTON
contains a BOTTLE
1
60 mL In 1 BOTTLE
This package is contained within the CARTON (41520-798-16)
2
41520-798-30
3 BOTTLE In 1 CARTON
contains a BOTTLE
2
60 mL In 1 BOTTLE
This package is contained within the CARTON (41520-798-30)
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA075598
12/15/2009
Labeler - American Sales Company (809183973)
Revised: 06/2009American Sales Company
More Careone Hair Regrowth Treatment for Men resources
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