KEEPS MINOXIDIL TOPICAL- minoxidil aerosol, foam

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

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Active ingredient:
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)
Available from:
THIRTY MADISON INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Hair regrowth treatment for men to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
Authorization status:
Abbreviated New Drug Application
Authorization number:
71713-092-30

KEEPS MINOXIDIL TOPICAL- minoxidil aerosol, foam

THIRTY MADISON INC

----------

Thirty Madison Inc Minoxidil Topical Aerosol 5% Foam Drug Facts

Active ingredient

Minoxidil 5% w/w (without propellant)

Purpos e

Hair regrowth treatment for men

Us e

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

Warnings

For external use only. For use by men only.

Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

Do not use if

Ask a doctor before use if you have

heart disease

When using this product

Stop use and ask a doctor if

you are a woman

your amount of hair loss is different than that shown on side of this carton or your hair loss is on

the front of the scalp. Minoxidil Topical Aerosol, 5% (Foam) 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

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 all men.

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. (1-800-222-1222)

Directions

Other Information

Inactive ingredients

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, dehydrated alcohol, isobutane, lactic acid,

polysorbate 60, propane, purified water, stearyl alcohol

Questions or comments?

1-800-719-9260

Consumer Information

IMPORTANT INFORMATION ABOUT

Minoxidil Topical Aerosol, 5% (Foam)

Hair Regrowth Treatment

UNSCENTED

For Men

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

apply half a capful 2 times a day to the scalp in the hair loss area

massage into scalp with fingers, then wash hands well

see enclosed leaflet for complete directions on how to use

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

hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used

it for 4 months

see hair loss pictures on side of this carton

before use, read all information on package and enclosed leaflet

keep the package. It contains important information.

store at 20-25°C (68-77°F)

contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at

temperatures above 120°F (49°C).

Not For Use By Women

SAVE LEAFLET FOR FUTURE REFERENCE

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.

Please read this leaflet carefully. It will help you understand how to use Minoxidil Topical Aerosol,

5% and what to expect from its use. If you have any questions after reading this leaflet, or anytime while

using Minoxidil Topical Aerosol, 5%, you should ask your healthcare professional or call us at 1-800-

719-9260.

What is Minoxidil Topical Aerosol, 5%?

Minoxidil Topical Aerosol, 5% is a white foam containing 5% minoxidil for use only on the scalp to

help regrow hair in men.

Who may use Minoxidil Topical Aerosol, 5%?

Minoxidil Topical Aerosol, 5% is for use only by men. Minoxidil Topical Aerosol, 5% may be

appropriate for you if you are a male at least 18 years old and experiencing gradually thinning hair or

gradual hair loss on the top of the scalp (vertex only, as shown below). It is not intended for frontal

baldness or a receding hairline. The common inherited thinning or hair loss process begins slowly and

may become noticeable only after years of gradual loss.

Minoxidil Topical Aerosol, 5% is for men with hair loss or thinning hair that begins on the vertex of

the scalp. Minoxidil Topical Aerosol, 5% is more likely to regrow hair in men with hair loss in the

range shown below. If men have more hair loss than shown, Minoxidil Topical Aerosol, 5% may not

work.

Many of those experiencing hair loss have other family members with gradually thinning hair or hair

loss. If you have no family history of gradually thinning hair or of gradual hair loss, or your hair

loss is patchy, see your doctor.

Who should NOT use Minoxidil Topical Aerosol, 5%?

Revitalizes Hair Follicles

Easy-To-Use Foam

Clinically Proven to Help Regrow Hair

Women should not use Minoxidil Topical Aerosol, 5%.

Minoxidil Topical Aerosol, 5% should not be used on babies or children under 18 years old.

Minoxidil Topical Aerosol, 5% will not prevent or improve hair loss which may occur with the

use of some prescription and non-prescription medications, certain severe nutritional problems

(very low body iron; too much vitamin A intake), low thyroid states (hypothyroidism),

Also, Minoxidil Topical Aerosol, 5% will not improve hair loss due to:

Do not use if you are not sure of the reason for your hair loss.

Will Minoxidil Topical Aerosol, 5% work for me?

The amount of hair regrowth is different for each person. Not everyone will respond to Minoxidil

Topical Aerosol, 5%. The response to Minoxidil Topical Aerosol, 5% cannot be predicted. It is

unlikely anyone will be able to grow back all their hair.

However, to see your best results with Minoxidil Topical Aerosol, 5% make sure you get the medicine

directly to the scalp and apply it twice a day, every day.

You may get better results if you have been losing your hair for a short period of time or have little hair

loss. However, for some men Minoxidil Topical Aerosol, 5% may not work.

How soon can I expect results from using Minoxidil Topical Aerosol, 5%?

Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with Minoxidil Topical

Aerosol, 5% also takes time.

Results may be seen as early as 2 months with twice daily use. For some men, it may take at least 4

months for results to be seen. If you do not see any results after 4 months, stop using Minoxidil Topical

Aerosol, 5% and seek the advice of your physician.

When you first begin to use Minoxidil Topical Aerosol, 5%, your hair loss may increase temporarily

for up to 2 weeks. This is likely a sign that you are getting rid of old hairs in order to regrow more new

hairs. This temporary increase in hair loss is expected and is part of the process for how Minoxidil

Topical Aerosol, 5% regrows hair. Remember, this increased hair loss is temporary. However, if it

continues after two weeks, see your physician.

If Minoxidil Topical Aerosol, 5% is working, what will the hair look like?

At first, hair growth is usually soft, downy, colorless hairs (like peach fuzz). After further use, the new

hairs should be the same color and thickness as the other hairs on your scalp.

How long do I need to use Minoxidil Topical Aerosol, 5%?

If you experience hair regrowth, continued use of Minoxidil Topical Aerosol, 5% is necessary or the

hair loss will begin again.

What happens if I completely stop using Minoxidil Topical Aerosol, 5%?

Continuous use of Minoxidil Topical Aerosol, 5% is needed to maintain hair regrowth. If you stop

using Minoxidil Topical Aerosol, 5%, you will lose your newly regrown hair in 3 to 4 months.

How do I use Minoxidil Topical Aerosol, 5%?

For best results, apply half a capful 2 times a day directly to the scalp in the hair loss area. Using more

than the recommended amount will not improve results. Each can should last one month, if used as

directed. Never take this product by mouth or apply to other parts of the body.

When do I use Minoxidil Topical Aerosol, 5%?

Apply Minoxidil Topical Aerosol, 5% once in the morning and once at night. Allow the nighttime

application to dry completely before going to bed. Each can should last one month, if used as directed.

chemotherapy, or diseases which cause scarring of the scalp.

damage from the use of hair care products which cause scarring or deep burns of the scalp.

hair grooming methods such as cornrowing or ponytails which require pulling the hair tightly

back from the scalp.

What if I miss a dose or forget to use Minoxidil Topical Aerosol, 5%?

If you miss one or two daily doses of Minoxidil Topical Aerosol, 5%, just continue with your next

dose. You should not make up for missed doses.

Can I use Minoxidil Topical Aerosol, 5% more than twice a day? Will it work faster, better?

No. Minoxidil Topical Aerosol, 5% will not work faster or better if used more than two times a day.

More frequent use or larger doses have not been shown to speed up hair growth and may increase your

chance of side effects.

What kind of shampoo should I use with Minoxidil Topical Aerosol, 5%?

If you wash your scalp before applying Minoxidil Topical Aerosol, 5% use a mild shampoo.

Can I use hair sprays, mousses, conditioners, gels, etc.?

Yes. Hair sprays, spritz, or styling aids may be used on your hair while using Minoxidil Topical

Aerosol, 5%. For best results, Minoxidil Topical Aerosol, 5% should be allowed to soak into the scalp

before using any styling products. Try to develop a good routine of applying Minoxidil Topical

Aerosol, 5% first, and then applying styling products and style as usual. Keep in mind that your best

results will be seen with proper application.

Can I have my hair colored or permed or use hair relaxers while using Minoxidil Topical

Aerosol, 5%?

Yes. We have no evidence that coloring or perming your hair or that the use of relaxers change the

effect of Minoxidil Topical Aerosol, 5%. However, because the use of a permanent wave and hair

color can cause scalp irritation on certain people, we recommend the following precautions:

Missing one day of Minoxidil Topical Aerosol, 5% will not affect your hair regrowth results.

Can I apply Minoxidil Topical Aerosol, 5% and wash my hair an hour later?

No. For Minoxidil Topical Aerosol, 5% to work best, you should allow it to stay on the scalp for about

4 hours before washing.

Using the product:

To avoid possible scalp irritation, you should make sure all of the Minoxidil Topical Aerosol,

5% has been washed off the hair and scalp before using color or perm chemicals.

For best results, do not apply Minoxidil Topical Aerosol, 5% on the same day that you use a

chemical treatment on your hair.

Do not use Minoxidil Topical Aerosol, 5% for 24 hours after using any chemicals to make sure

your scalp has not been irritated by the perm or color treatment. If no irritation occurs, continue

use of Minoxidil Topical Aerosol, 5% as usual.

Simply restart your normal Minoxidil Topical Aerosol, 5% routine. There is no need to use more

Minoxidil Topical Aerosol, 5% to make up for missed applications.

To open container: Match arrow on can ring with arrow on cap. Pull off cap.

Within the hair thinning area, part the hair into one or more rows to maximize scalp exposure.

The foam may begin to melt right away on contact with your warm skin. If your fingers are warm,

rinse them in cold water first. (Be sure to dry them thoroughly before handling the foam.)

Hold the can straight upside down and press nozzle to dispense the topical foam product onto your

fingers. The total amount of foam applied should not exceed half a capful.

Using your fingers, spread the foam over the hair loss area and gently massage into scalp and then

wash your hands well.

After each use, close the container to make child resistant by snapping the cap back on to the can.

Warnings :

For external use only

For use by men only

Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

Do not use if

Ask a doctor before use if you have heart disease.

When using this product

Stop use and ask a doctor if

you are a woman

your amount of hair loss is different than that shown on the other side of this leaflet or your hair

loss is on the front of the scalp. Minoxidil Topical Aerosol, 5% 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

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 may experience 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.

chest pain, rapid heartbeat, faintness, or dizziness occurs

sudden, unexplained weight gain occurs

your hands or feet swell

Not for use by women.

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 (1-800-222-1222).

What are the most common side effects with Minoxidil Topical Aerosol, 5%?

The most common side effects are itching and skin irritation of the treated area of the scalp. If scalp

irritation continues, stop use and see a doctor. Minoxidil Topical Aerosol, 5% contains alcohol, which

will cause burning or irritation of the eyes. If Minoxidil Topical Aerosol, 5% accidentally gets into

eyes, rinse with large amounts of cool tap water.

Can Minoxidil Topical Aerosol, 5% produce unwanted hair growth?

Unwanted hair growth on the face and other parts of the body has been reported in women. But it is rare

and reversible. If you develop unwanted hair, stop using Minoxidil Topical Aerosol, 5%. Over time, the

unwanted hair growth caused by Minoxidil Topical Aerosol, 5% will go away. You can take the

following steps to decrease the chances of unwanted hair growth:

Can I use Minoxidil Topical Aerosol, 5% for baldness or hair loss in babies or children?

No. Minoxidil Topical Aerosol, 5% must not be used to treat baldness or hair loss in babies and

children.

If you have any other questions, ask your healthcare professional or call us at 1-800-719-9260.

Store at 20-25°C (68-77°F).

Save this leaflet for future reference

To Open:

To Close:

scalp irritation or redness occurs

unwanted facial hair growth occurs

limit the application of Minoxidil Topical Aerosol, 5% only to the scalp;

if you use your hands to apply Minoxidil Topical Aerosol, 5%, wash your hands well immediately

afterwards.

Hold RING (See diagram)

While holding RING twist CAP to line up arrow on RING with arrow on CAP.

Tilt CAP back and pull

Place CAP on container and snap into place.

Be sure arrows DO NOT line up so CAP remains child resistant.

Made in Israel

Distributed By

Perrigo®

Allegan, MI 49010

Rev 12-14

: 29400 00 J3

Package/Label Principal Display Panel

Minoxidil Topical Aerosol, 5% (Foam)

Revitalizes Hair Follicles

Clinically Proven to Help Regrow Hair

Easy-To-Use Foam Unscented

HAIR REGROWTH TREATMENT FOR MEN

NOT FOR USE BY WOMEN

#1 Dermatologist Recommended Active Ingredient

THREE MONTH SUPPLY

THREE 60 g (2.11 OZ) CANS

TOTAL 180 g (6.33 OZ)

KEEPS MINOXIDIL TOPICAL

minoxidil aerosol, foam

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71713-0 9 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 g

Inactive Ingredients

Ingredient Name

Stre ng th

BUTANE (UNII: 6 LV4FOR43R)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

THIRTY MADISON INC

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ISO BUTANE (UNII: BXR49 TP6 11)

LACTIC ACID (UNII: 33X0 4XA5AT)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

PRO PANE (UNII: T75W9 9 11L6 )

WATER (UNII: 0 59 QF0 KO0 R)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71713-0 9 2-30

3 in 1 CARTON

0 7/23/20 19

1

6 0 g in 1 CAN; 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 9 1344

0 7/23/20 19

Labeler -

T HIRT Y MADISON INC (080774087)

Revised: 7/2019

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