EXT HAIR REGROWTH TREATMENT FOR MEN 5%- minoxidil 5% solution 
TTEM, LLC

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EXT Hair Regrowth Treatment for Men 5%

Minoxidil 5% w/v

Hair regrowth treatment for men

USE

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

For external use only

Flammable: Keep away from fire or flame

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 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 everyone.

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

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

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 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 an observational study of 733 male subjects, more than 63% of

participants found EXT Hair Regrowth Treatment to be eective or very

eective in hair regrowth.

■ store at controlled room temperature between 68° - 77°F

(20°-25°C). Keep tightly closed.

Inactive ingredients

alcohol, propylene glycol, purified water

box

EXT HAIR REGROWTH TREATMENT FOR MEN 5% 
minoxidil 5% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70150-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70150-003-011 in 1 BOX09/10/2019
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623909/10/2019
Labeler - TTEM, LLC (079997910)

Revised: 9/2019
Document Id: 923fac96-95ee-77fc-e053-2a95a90ae83a
Set id: 923fac96-95ed-77fc-e053-2a95a90ae83a
Version: 1
Effective Time: 20190910
 
TTEM, LLC