MINOXIDIL 5% (FOR MEN) - minoxidil aerosol, foam 
Aurohealth LLC

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Drug Facts

Active ingredient

Minoxidil USP 5% w/w (without propellant)

Purpose

Hair regrowth treatment for men

Use

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

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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

Alcohol, anhydrous citric acid, butane, butylated hydroxy toluene, cetyl alcohol, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, stearyl alcohol


Questions?

Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India
Code: TS/DRUGS/58039/2020

IMPORTANT INFORMATION ABOUT

Minoxidil Topical Aerosol 5% (For Men)

HAIR REGROWTH TREATMENT


REACTIVATES

HAIR FOLLICLES TO STIMULATE REGROWTH


EASY-TO-USE

FOAM

CLINICALLY PROVEN TO HELP REGROW HAIR


UNSCENTED


Not For Use By Women

Minoxidil Topical Aerosol  5% (For Men)

HAIR REGROWTH TREATMENT

Save booklet for future reference


Please read this booklet carefully. It will help you understand how to use Minoxidil Topical Aerosol 5% (Foam) and what to expect from its use. If you have any questions after reading this booklet, or anytime while using Minoxidil Topical Aerosol 5% (Foam), you should ask your health care professional or call us at 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST).

What is Men's Minoxidil Topical Aerosol 5% (Foam)?

Minoxidil Topical Aerosol 5% (Foam) is a white foam containing 5% minoxidil for use only on the scalp to help regrow hair in men.


Who may use Men's Minoxidil Topical Aerosol 5% (Foam)?

Minoxidil Topical Aerosol 5% (Foam) is for use only by men. Minoxidil Topical Aerosol 5% (Foam) 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 on the next page). 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% (Foam) is for men with hair loss or thinning hair that begins on the vertex of the scalp. Minoxidil Topical Aerosol 5% (Foam) is more likely to regrow hair in men with hair loss in the range shown on the next page. If men have more hair loss than shown, Minoxidil Topical Aerosol 5% (Foam) may not work.



fig

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 Men's Minoxidil Topical Aerosol 5% (Foam)?


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

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

Will Men's Minoxidil Topical Aerosol 5% (Foam) work for me?

The amount of hair regrowth is different for each person. Not everyone will respond to Minoxidil Topical Aerosol 5% (Foam). The response to Men's Minoxidil Topical Aerosol 5% (Foam) cannot be predicted. It is unlikely anyone will be able to grow back all their hair.


However, to see your best results with Men's Minoxidil Topical Aerosol 5% (Foam), 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% (Foam) may not work.

How soon can I expect results from using Men's Minoxidil  Topical Aerosol 5% (Foam)?

Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with Minoxidil Topical Aerosol 5% (Foam) 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% (Foam) and seek the advice of your physician.


When you first begin to use Minoxidil Topical Aerosol 5% (Foam), 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% (Foam) regrows hair. Remember, this increased hair loss is temporary. However, if it continues after two weeks, see your physician.


If Men's Minoxidil Topical Aerosol  5% (Foam) 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 Men's Minoxidil Topical Aerosol 5% (Foam)?

If you experience hair regrowth, continued use of Minoxidil Topical Aerosol 5% (Foam) is necessary or the hair loss will begin again.

What happens if I completely stop using Men's Minoxidil Topical Aerosol 5% (Foam)?

Continuous use of Minoxidil Topical Aerosol 5% (Foam) is needed to maintain hair regrowth.


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


How do I use Men's Minoxidil Topical Aerosol 5% (Foam)?

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 Men's Minoxidil Topical Aerosol 5% (Foam)?

Apply Minoxidil Topical Aerosol 5% (Foam) once in the morning and once at night. Allow the night time application to dry completely before going to bed. Each can should last one month, if used as directed.

What if I miss a dose or forget to use Men's Minoxidil Topical Aerosol 5% (Foam)?

If you miss one or two daily doses of Minoxidil Topical Aerosol 5% (Foam), just continue with your next dose. You should not make up for missed doses.



Can I use Men's Minoxidil Topical Aerosol 5% (Foam) more than twice a day? Will it work faster, better?

No. Minoxidil Topical Aerosol 5% (Foam) 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 Men's Minoxidil Topical Aerosol 5% (Foam)?

If you wash your scalp before applying Minoxidil Topical Aerosol 5% (Foam), 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% (Foam). For best results, Minoxidil Topical Aerosol 5% (Foam) 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% (Foam) 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 Men's Minoxidil Topical Aerosol  5% (Foam)?

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% (Foam). However, because the use of a permanent wave and hair color can cause scalp irritation on certain people, we recommend the following precautions:

  1. To avoid possible scalp irritation, you should make sure all of the Minoxidil Topical Aerosol 5% (Foam) has been washed off the hair and scalp before using color or perm chemicals.
  2. For best results, do not apply Minoxidil Topical Aerosol 5% (Foam) on the same day that you use a chemical treatment on your hair.
  3. Do not use Minoxidil Topical Aerosol 5% (Foam) 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% (Foam) as usual.
  4. Simply restart your normal Minoxidil Topical Aerosol 5% (Foam) routine. There is no need to use more Minoxidil Topical Aerosol 5% (Foam) to make up for missed applications.

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

Can I apply Men's Minoxidil Topical Aerosol 5% (Foam) and wash my hair an hour later?

No. For Minoxidil Topical Aerosol 5% (Foam) to work best, you should allow it to stay on the scalp for about 4 hours before washing.

Using the Product:

1: PREP HANDS WITH COLD WATER

Rinse your fingers in cold water and dry them. Note: foam will melt on contact with warm surfaces.

fig

2: OPEN CHILD RESISTANT CAP

Be sure to align arrow on the cap with arrow on white ring. Tilt cap back and pull off.

fig

3: DISPENSE VERTICALLY ONTO A COLD SURFACE

Hold the can straight upside down. If you hold the can at an angle, foam may not dispense properly. Press nozzle to dispense half a capful of foam onto cold surface (e.g. dish, or cold hands).
fig
fig

4: APPLY TO SCALP, NOT HAIR

Part your hair to expose hair loss area. Massage foam into scalp, not hair. Repeat until all hair loss areas have been covered.

fig

5: CLOSE CAP AND WASH HANDS

Snap cap back into place. Be sure arrows do not line up, so cap remains child resistant. Wash hands and any surface thoroughly after use.

fig

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 your doctor before use if you have heart disease.

When using this product

  Stop use and ask a doctor if

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 (1-800-222-1222) right away.

What are the most common side effects with Men's Minoxidil Topical Aerosol  5% (Foam)?

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% (Foam) contains alcohol, which will cause burning or irritation of the eyes. If Minoxidil Topical Aerosol 5% (Foam) accidentally gets into eyes, rinse with large amounts of cool tap water.

Can Men's Minoxidil Topical Aerosol  5% (Foam) 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% (Foam). Over time, the unwanted hair growth caused by Minoxidil Topical Aerosol 5% (Foam) will go away. You can take the following steps to decrease the chances of unwanted hair growth:

  1. limit the application of Minoxidil Topical Aerosol 5% (Foam) only to the scalp;
  2. if you use your hands to apply Minoxidil Topical Aerosol 5% (Foam), wash your hands well immediately afterwards.

Can I use Men's Minoxidil Topical Aerosol 5% (Foam) for baldness or hair loss in babies or children?

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


If you have any other questions, ask your health care professional or call us at 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST).


Store at  20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).  

Save this booklet for future reference. 

•   To Open:

  1. Be sure to align arrow on the cap with arrow on white ring.
  2. Tilt cap back and pull off.

•   To Close:

  1. Place CAP on container and snap into place.
  2. Be sure arrows DO NOT  line up so CAP  remains child resistant.

 fig

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520


Questions? call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST).

Revised: 01/2024

PRINCIPAL DISPLAY PANEL - One 60 g Can Label

AUROHEALTH

NDC 58602-608-01


FOR BEST RESULTS
USE TWICE DAILY
APPLY DIRECTLY TO SCALP


Minoxidil
Topical
Aerosol 5%
(For Men)

HAIR REGROWTH
TREATMENT

REACTIVATES
HAIR FOLLICLES
TO STIMULATE REGROWTH

EASY-TO-USE FOAM

UNSCENTED

Not For Use By Women

One Month Supply
One 60 g (2.11 OZ) Can

fig

PRINCIPAL DISPLAY PANEL - One 60 g Can Carton

AUROHEALTH

NDC 58602-608-01

*Compare to the active ingredient
of Men's Rogaine®

Minoxidil Topical
Aerosol 5% (For Men)

HAIR REGROWTH TREATMENT

REACTIVATES

HAIR FOLLICLES
TO STIMULATE REGROWTH

EASY-TO-USE
FOAM

CLINICALLY PROVEN TO HELP REGROW HAIR

UNSCENTED

Not For Use By Women

One Month Supply • One 60 g (2.11 oz) Can
figure

MINOXIDIL 5% (FOR MEN) 
minoxidil aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-608
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTANE (UNII: 6LV4FOR43R)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOBUTANE (UNII: BXR49TP611)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPANE (UNII: T75W9911L6)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-608-011 in 1 CARTON04/22/2024
160 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:58602-608-022 in 1 CARTON04/22/2024
260 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:58602-608-033 in 1 CARTON04/22/2024
360 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:58602-608-044 in 1 CARTON04/22/2024
460 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC:58602-608-056 in 1 CARTON04/22/2024
560 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21861604/22/2024
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED878100017ANALYSIS(58602-608) , MANUFACTURE(58602-608)

Revised: 5/2024
Document Id: e6b3b997-cde9-476d-b08c-4d1010456d8b
Set id: e6b3b997-cde9-476d-b08c-4d1010456d8b
Version: 1
Effective Time: 20240502
 
Aurohealth LLC