MINOXIDIL 5% (FOR WOMEN) - 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 women

Use

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

Warnings

For external use 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 Women)

Hair Regrowth Treatment

REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH

 

CLINICALLY PROVEN TO REGROW HAIR

 

Oncea-Day

Foam For Women

 

UNSCENTED


Minoxidil Topical Aerosol 5% (For Women)

Hair Regrowth Treatment


Save this booklet for future reference.


Please read this booklet carefully. It will help you understand how to use Women’s Minoxidil Topical Aerosol 5% (Foam) and what to expect from its use. It takes time to regrow hair. Results may occur at 3 months with once daily usage. For some women, you may needed to use this product for at least 6 months before you see results. If you have any questions after reading this booklet, or anytime while using Women’s Minoxidil Topical Aerosol 5% (Foam), you should ask your health care professional or call us at toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST).

WHAT IS WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

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

  

WHO MAY USE WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

  

Women’s Minoxidil Topical Aerosol 5% (Foam) may be appropriate for you if you are an adult who is at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of the scalp. The common hereditary thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss.

  

Women’s Minoxidil Topical Aerosol 5% (Foam) is for general thinning of hair on the top of the scalp as shown on the next page. Women’s Minoxidil Topical Aerosol 5% (Foam) has been shown to regrow hair in women with the degrees of hair loss shown. If women have more hair loss than shown, Women’s Minoxidil Topical Aerosol 5% (Foam) may not work.

  

Many of those experiencing hair loss have other family members with gradual thinning hair or hair loss. If there is no family history of gradual thinning or gradual hair loss, or hair loss is patchy, see your doctor.
figure
WHO SHOULD NOT USE WOMEN’S MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

Women’s Minoxidil Topical Aerosol 5% (Foam) will not prevent or improve hair loss related to pregnancy, the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; excessive vitamin A intake), the recently discontinued use of birth control pills, low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp. Also, Women’s 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 WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM) WORK FOR ME?

  

The amount of hair regrowth is different for each person. Not everyone will respond to Women’s Minoxidil Topical Aerosol 5% (Foam). The response to Women’s Minoxidil Topical Aerosol 5% (Foam) cannot be predicted. No one will be able to grow back all their hair.

To see your best results with Women’s Minoxidil Topical Aerosol 5% (Foam), make sure you apply the product directly to the scalp once daily. For some Women’s Minoxidil Topical Aerosol 5% (Foam) may not work.

  

HOW SOON CAN I EXPECT RESULTS FROM USING WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?


Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with Women’s Minoxidil Topical Aerosol 5% (Foam) also takes time. Generally, new hair growth is slow for a Women’s Minoxidil Topical Aerosol 5% (Foam) user. Results may be seen as early as 3 months with once daily use. For some women, it may take at least 6 months for results to be seen. If you do not see any results after 6 months, stop using Women’s Minoxidil Topical Aerosol 5% (Foam) and seek the advice of your doctor.

  

When you first begin to use Women’s Minoxidil Topical Aerosol 5% (Foam), your hair loss may continue for up to 2 weeks. This increase in hair loss is expected and is temporary. However, if it continues after two weeks, see your physician.

IF WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM) IS WORKING, WHAT WILL THE HAIR LOOK LIKE?

  

At first, hair growth may be soft, downy, and colorless hairs. 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 WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

  

If you respond to Women’s Minoxidil Topical Aerosol 5% (Foam), you need to use it once daily to keep and continue the hair regrowth. Up to 3 months of usage may be needed to see your best results from Women’s Minoxidil Topical Aerosol 5% (Foam).

  

WHAT HAPPENS IF I COMPLETELY STOP USING WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)? WILL I KEEP THE NEW HAIR?

  

Continuous use of Women’s Minoxidil Topical Aerosol 5% (Foam) is needed to maintain hair regrowth. If you stop using Women’s Minoxidil Topical Aerosol 5% (Foam), the normal hair loss process will start again. You will probably lose your newly regrown hair in three to four months.

  

HOW DO I USE WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

  

For best results, apply half a capful once 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 two months, if used as directed. Never take this product by mouth or apply to other parts of the body. Please refer to the “Directions for Use” section of this booklet.

WHEN DO I USE WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

  

Apply Women’s Minoxidil Topical Aerosol 5% (Foam) once daily. If you apply at night, allow application to dry completely before going to bed.

  

WHAT IF I FORGET TO USE WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM) OR MISS A DOSE?

  

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

  

CAN I USE WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM) MORE THAN ONCE A DAY? WILL IT WORK FASTER, BETTER?

  

No. Women’s Minoxidil Topical Aerosol 5% (Foam) will not work faster or better if used more than once 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 WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

  

If you wash your scalp before applying Women’s Minoxidil Topical Aerosol 5% (Foam), use a mild shampoo.

CAN I USE HAIR SPRAYS, MOUSSES, CONDITIONERS, GELS, ETC.?

  

Yes. There is no reason to change your usual hair care routine when using Women’s Minoxidil Topical Aerosol 5% (Foam). However, you should apply Women’s Minoxidil Topical Aerosol 5% (Foam) first and wait for it to dry before applying your styling aids.

  

CAN I HAVE MY HAIR COLORED OR PERMED OR USE HAIR RELAXERS WHILE USING WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

  

Yes. We have no evidence that coloring or perming, or using relaxers on your hair change the effect of Women’s 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 Women’s 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 Women’s Minoxidil Topical Aerosol 5% (Foam) on the same day that you use a chemical treatment on your hair.
  3. Do not use Women’s 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 Women’s Minoxidil Topical Aerosol 5% (Foam) as usual.
  4. Simply restart your normal Women’s Minoxidil Topical Aerosol 5% (Foam) routine. There is no need to use more Women’s Minoxidil Topical Aerosol 5% (Foam) to make up for missed applications.

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

CAN I APPLY WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)  AND WASH MY HAIR AN HOUR LATER?

  

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

 DIRECTIONS FOR USE:





1: PREP HANDS WITH COLD WATER

Rinse your fingers in cold water and dry them. Note: foam will melt on contact with warm surfaces.
figure
2: OPEN CHILD RESISTANT CAP

Be sure to align arrow on the cap with arrow on white ring. Tilt cap back and pull off.
figure
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 a cold, surface (e.g. dish, or cold hands).

figure

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.

figure

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. 

 figure

 ARE THERE ANY SPECIAL WARNINGS ABOUT THE USE OF WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

Warnings:   

For external use 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

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 WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?


The most common side effects are itching and other skin irritation of the treated area of the scalp. Women’s Minoxidil Topical Aerosol 5% (Foam) contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If Women’s Minoxidil Topical Aerosol 5% (Foam) accidentally gets into these areas, rinse with large amounts of cool tap water. Stop using Women’s Minoxidil Topical Aerosol 5% (Foam) and contact your doctor if irritation persists.

CAN WOMEN
S MINOXIDIL TOPICAL AEROSOL 5% (FOAM) PRODUCE UNWANTED HAIR?


Unwanted hair growth has been reported on the face and on other parts of the body with Women’s Minoxidil Topical Aerosol 5% (Foam) use. The unwanted hair growth may be caused by the transfer of Women’s Minoxidil Topical Aerosol 5% (Foam) to areas other than the scalp, or by absorption into the circulatory system of low levels of the active ingredient, or by a medical condition not related to the use of Women’s Minoxidil Topical Aerosol 5% (Foam).

  

If you experience unwanted hair, discontinue using Women’s Minoxidil Topical Aerosol 5% (Foam) and see your doctor for recommendations about appropriate treatment. After stopping use of Women’s Minoxidil Topical Aerosol 5% (Foam), the unwanted hair, if caused by the use of Women’s Minoxidil Topical Aerosol 5% (Foam), should go away over time.  You can take steps to decrease the chances for unwanted hair growth:

  1. Limit the application of Women’s Minoxidil Topical Aerosol 5% (Foam) only to the scalp;
  2. If you use your hands to apply Women’s Minoxidil Topical Aerosol 5% (Foam), wash your hands thoroughly afterwards, and
  3. Allow sufficient drying time before going to bed (usually 2 to 4 hours before going to bed after applying Women’s Minoxidil Topical Aerosol 5% (Foam).

CAN I USE WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM) FOR BALDNESS OR HAIR LOSS IN BABIES OR CHILDREN?

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

  

WHAT FACTORS MAY INCREASE THE RISK OF SERIOUS SIDE EFFECTS WITH WOMENS MINOXIDIL TOPICAL AEROSOL 5% (FOAM)?

Women’s Minoxidil Topical Aerosol 5% (Foam) should be applied only to the scalp. The risk of side effects may be greater when Women’s Minoxidil Topical Aerosol 5% (Foam) is applied to other parts of the body.

  

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

Store at 20°C to 25°C (68°F 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.

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 58602-607-01


Minoxidil
Topical
Aerosol 5%
(FOR WOMEN)

HAIR REGROWTH
TREATMENT

REACTIVATES
HAIR FOLLICLES
TO STIMULATE REGROWTH

CLINICALLY PROVEN
TO REGROW HAIR

Once-a-Day
Foam For Women

UNSCENTED

Two Month Supply
One 60 g (2.11 OZ) Can
fig

PRINCIPAL DISPLAY PANEL - One 60 g Can Carton

AUROHEALTH

NDC 58602-607-01

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

Minoxidil Topical
Aerosol 5% (FOR WOMEN)

HAIR REGROWTH TREATMENT

REACTIVATES
HAIR FOLLICLES
TO STIMULATE REGROWTH

Once-a-Day
Foam For Women

CLINICALLY PROVEN TO REGROW HAIR


UNSCENTED

TWO MONTH SUPPLY
ONE 60 g (2.11 OZ) CAN

 fig

MINOXIDIL 5% (FOR WOMEN) 
minoxidil aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-607
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:58602-607-011 in 1 CARTON04/22/2024
160 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:58602-607-022 in 1 CARTON04/22/2024
260 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:58602-607-033 in 1 CARTON04/22/2024
360 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:58602-607-044 in 1 CARTON04/22/2024
460 g in 1 CAN; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC:58602-607-056 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(58602-607) , MANUFACTURE(58602-607)

Revised: 5/2024
Document Id: dbda95f2-11a8-4b2f-af45-b791342fff70
Set id: dbda95f2-11a8-4b2f-af45-b791342fff70
Version: 1
Effective Time: 20240502
 
Aurohealth LLC