ROOTS PROFESSIONAL - TOPICAL SOLUTION HAIR REGROWTH TREATMENT- minoxidil 5% solution

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

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Active ingredient:
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)
Available from:
Roots Hair Club, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Hair regrowth treatment for men Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton). Do not use if: - You are a woman - Your amount of hair loss is different than shown on the side of this carton or hair loss is on the front of the scalp, 5% minoxidil topical solution 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 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 - Chest pain, rapid heart beat, faintness, or dissiness occurs - Sudden, unexplained weight gain occurs - Your hands of feet swell - Scalp irritation or redness occurs - You get unwanted facial hair growth - You do not see hair regrowth in 4 months
Authorization status:
Abbreviated New Drug Application
Authorization number:
73359-002-01

ROOTS PROFESSIONAL - TOPICAL SOLUTION HAIR REGROWTH TREATMENT-

minoxidil 5% solution

Roots Hair Club, LLC

----------

Roots Professional - 5% Minoxidil Topical Solution Hair Regrowth Treatment

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).

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Do not use if:

You are a woman

Your amount of hair loss is different than shown on the side of this carton or hair loss is on the front

of the scalp, 5% minoxidil topical solution 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 or children

Your scalp is red, inflamed, infected, irritated, or painful

You use other medicines on the scalp

Ask your 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 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 all men

Stop use and ask a doctor if

Chest pain, rapid heart beat, faintness, or dissiness occurs

Sudden, unexplained weight gain occurs

Your hands of feet swell

Scalp irritation or redness occurs

You get unwanted facial hair growth

You do not see hair regrowth in 4 months

DIRECTIONS

apply 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area

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

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

Hair regrowth has not been shown to last longer than 48 weeks in large clinical trialse with

continuous treatment with 5% minoxidil topical solution for men

In clincial studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5%

minoxidil topical solution for men provide more hair regrowth than 2% minoxidil topical solution

Store at controlled room temperature 20

to 25

C (68

to 77

Alcohol, Propylene Glycol, Purified Water

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

away.

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

ROOTS PROFESSIONAL - TOPICAL SOLUTION HAIR REGROWTH

TREATMENT

minoxidil 5% solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73359 -0 0 2

Route of Administration

TOPICAL

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

5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

WATER (UNII: 0 59 QF0 KO0 R)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:73359 -0 0 2-0 1

1 in 1 BOX

0 9 /11/20 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 76 239

0 9 /11/20 19

Roots Hair Club, LLC

Labeler -

Roots Hair Club, LLC (117159782)

Revised: 9/2019

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