FDA Label for Ext Hair Regrowth Treatment For Men 2%
View Indications, Usage & Precautions
Ext Hair Regrowth Treatment For Men 2% Product Label
The following document was submitted to the FDA by the labeler of this product Ttem, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Minoxidil 2% w/v
Use
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of the carton).
Otc - Purpose
Hair regrowth treatment
Warnings
For external use only
Flammable: Keep away from fire or flame
Otc - Do Not Use
Do not use if
■ you are a woman ■ your amount of hair loss is dierent than that
shown on the side of this carton, or your hair loss is on the front of the
scalp. EXT Hair Regrowth Treatment 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
Otc - Ask Doctor
Ask a doctor before use if you have heart disease
Otc - When Using
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 dierent for each person. This
product will not work for everyone.
Otc - Stop Use
Stop use and ask a doctor if
■ side eects occur. You may report side eects to FDA at
1.800.FDA.1088
■ 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
Otc - Pregnancy Or Breast Feeding
May be harmful if used when pregnant or breast-feeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
■ apply one mL with dropper 2 times a day directly onto the scalp in
the area of hair loss
■ 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 Safety Information
Other information
■ see hair loss pictures on side of this carton
■ before use, read all information on carton and enclosed leaflet
■ keep this carton. It contains important information.
■in clinical studies of mostly white men aged 18-49 years with moderate
degrees of hair loss, the following response to minoxidil topical solution
2% was reported: 26% of men reported moderate to dense hair regrowth
after using minoxidil topical solution 2% for 4 months (26% had
moderate to dense regrowth; 33% had minimal regrowth). This compares
with 11% of men reporting hair regrowth after using the placebo, the
liquid without minoxidil in it, for 4 months (11% had moderate to dense
regrowth; 31% had minimal regrowth).
■ store at controlled room temperature between 68° - 77°F
(20°-25°C). Keep tightly closed.
Inactive Ingredient
Inactive ingredients
alcohol, propylene glycol, purified water
* Please review the disclaimer below.