Ext Hair Regrowth Treatment For Men 5%

Ext Hair Regrowth Treatment For Men 5%
SPL v2
SPL
SPL Set ID 923fac96-95ed-77fc-e053-2a95a90ae83a
Route
TOPICAL
Published
Effective Date 2019-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Isopropyl Alcohol Propylene Glycol Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2019-09-10

Description

Minoxidil 5% w/v


Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable: Keep away from fire or flame

Description

Minoxidil 5% w/v

Use

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Section 50567-7

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.

Section 50569-3

Ask a doctor before use if you have heart disease

Section 50570-1

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

Section 51727-6

Inactive ingredients

alcohol, propylene glycol, purified water

Section 51945-4

Section 53414-9

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

Section 55105-1

Hair regrowth treatment for men

Section 55106-9

Minoxidil 5% w/v

Section 60561-8

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.

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.


Structured Label Content

Use (USE)

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable: Keep away from fire or flame

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have heart disease

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

alcohol, propylene glycol, purified water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Hair regrowth treatment for men

Section 55106-9 (55106-9)

Minoxidil 5% w/v

Section 60561-8 (60561-8)

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.

Directions (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.


Advanced Ingredient Data


Raw Label Data

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