EXT HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)
Available from:
TTEM, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Use to regrow hair on the scalp Hair regrowth treatment Do not use if: - Your degree of hair loss is different than shown on the side of this carton, because this product may not work for you - You have no family history of hair loss - Your hair loss is sudden and/or patchy - Your hair loss is associated with childbirth - You do not know the reason for your hair loss - You are under 18 years of age. Do not use on babies or children - Your scalp is red, inflamed, infected, irritated, or painful - You use other medicines on the scalp 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
70150-001-01

EXT HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil 2% solution

TTEM, LLC

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EXT Hair Regrowth Treatment for Women

USE

Use to regrow hair on the scalp

Hair regrowth treatment

For external use only.

Flamable: Keep away from fire of flame.

Do not use if:

Your degree of hair loss is different than shown on the side of this carton, because this product may

not work for you

You have no family history of hair loss

Your hair loss is sudden and/or patchy

Your hair loss is associated with childbirth

You do not know the reason for your hair loss

You are under 18 years of age. Do not use on babies or 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

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 expereinced 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

Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area

Using more or more ofthen will not improve results

Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

See hair loss pictures on the side of this carton

Before use, read all information on carton and enclosed leaflet

Keep the carton. It contains important information

In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the

following responses to 2% minoxidil topical solution was reported: 19% of women reported

moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate

regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting

moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7%

had moderate regrowth; 33% had minimal regrowth).

Store at controlled room temperature 20

to 25

C (68

to 77

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

EXT HAIR REGROWTH TREATMENT FOR WOMEN

minoxidil 2% solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 150 -0 0 1

Route of Administration

TOPICAL

TTEM, LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MINO XIDIL (UNII: 59 6 5120 SH1) (MINOXIDIL - UNII:59 6 5120 SH1)

MINOXIDIL

2 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

WATER (UNII: 0 59 QF0 KO0 R)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 150 -0 0 1-0 1

1 in 1 BOX

0 9 /10 /20 19

1

6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 78 176

0 9 /10 /20 19

Labeler -

T T EM, LLC (079997910)

Revised: 9/2019

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