REGOXIDINE  (FOR WOMEN)- minoxidil aerosol, foam 
Innovus Pharmaceuticals, Inc.

----------

Regoxidine®
5% (For Women)

Drug Facts

Active ingredient

Minoxidil 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

  • your degree of hair loss is different than that shown on 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 and 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

When using this product

  • do not use more than directed
  • 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 3 months with once-daily use. For some women, you may need to use this product once a day for at least 6 months before you see results.
  • the amount of hair regrowth is different for each person. This product will not work for all women.

Stop use and ask a doctor if

  • 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 6 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 (1-800-222-1222).

Directions

Other information

Inactive ingredients

butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

Distributed by:
Innovus Pharmaceuticals, Inc.
Englewood, CO 80112

PRINCIPAL DISPLAY PANEL - Two 60 g Can Package

NDC 57483-540-31

Crcle

Regoxidine®

Minoxidil Topical
Aerosol, 5%
(For Women)

Hair Regrowth
Treatment

ONCE-A-DAY
FOAM
for Women

Unscented

Reactivates Hair Follicles to
Stimulate Regrowth

Clinically Proven to Regrow Hair

#1 Dermatologist Recommended Active Ingredient
*Compare to the active ingredient of Women's Rogaine®

FOUR MONTH SUPPLY
TWO 2.11 OZ (60 g) CANS

PRINCIPAL DISPLAY PANEL - Two 60 g Can Package
REGOXIDINE   (FOR WOMEN)
minoxidil aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-540
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
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
cetyl alcohol (UNII: 936JST6JCN)  
anhydrous citric acid (UNII: XF417D3PSL)  
ALCOHOL (UNII: 3K9958V90M)  
isobutane (UNII: BXR49TP611)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
BUTANE (UNII: 6LV4FOR43R)  
polysorbate 60 (UNII: CAL22UVI4M)  
propane (UNII: T75W9911L6)  
WATER (UNII: 059QF0KO0R)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Product Characteristics
ColorWHITE (white to off-white foam) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57483-540-312 in 1 PACKAGE11/12/2019
160 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20907404/22/2019
Labeler -  Innovus Pharmaceuticals, Inc. (962507187)

Revised: 12/2022
Document Id: 61359d4f-de10-41f1-a795-f2ae3bda5b1d
Set id: b60cc177-700c-4007-be1a-2cb74824e657
Version: 3
Effective Time: 20221216
 
Innovus Pharmaceuticals, Inc.