EXT HAIR REGROWTH TREATMENT FOR MEN 2%- minoxidil 2% solution

EXT Hair Regrowth Treatment for Men 2% by

Drug Labeling and Warnings

EXT Hair Regrowth Treatment for Men 2% by is a Otc medication manufactured, distributed, or labeled by TTEM, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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).

PURPOSE

Hair regrowth treatment

WARNINGS

For external use only

Flammable: Keep away from fire or flame

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

Ask a doctor before use if you have heart disease

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.

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

PREGNANCY OR BREAST FEEDING

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

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

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)