Label: EXT HAIR REGROWTH TREATMENT FOR MEN 2%- minoxidil 2% solution
- NDC Code(s): 70150-002-01
- Packager: TTEM, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated September 10, 2019
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
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
- ASK DOCTOR
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.
Stop use and ask a doctor if
■ side eects occur. You may report side eects to FDA at
■ 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
OTHER SAFETY 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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EXT HAIR REGROWTH TREATMENT FOR MEN 2%
minoxidil 2% solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70150-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 2 g in 100 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70150-002-01 1 in 1 BOX 09/10/2019 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078176 09/10/2019 Labeler - TTEM, LLC (079997910)