Minoxidil Mens Topical Aerosol

Minoxidil Mens by

Drug Labeling and Warnings

Minoxidil Mens by is a Otc medication manufactured, distributed, or labeled by ROMAN HEALTH VENTURES INC., Taro Pharmaceutical Industries Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINOXIDIL MENS- minoxidil aerosol, foam 
ROMAN HEALTH VENTURES INC.

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Minoxidil Mens Topical Aerosol

Drug Facts

Active ingredient

Minoxidil 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

  • 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. 5% minoxidil topical 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

Ask a doctor before use if you haveheart 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 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.

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 4 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

  • 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

Other information

  • 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 carton and enclosed leaflet
  • keep the carton. It contains important information.
  • store at controlled room temperature 20° to 25°C (68° to 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).

Inactive ingredients

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

Questions?

  • Call 1-866-923-4914

Distributed by:
Roman Health Ventures, Inc.
116 W. 23rd Street, 4th Floor
New York, NY 10011

PRINCIPAL DISPLAY PANEL - Three 60 g Can Package

THIS ITEM IS
ELECTRONICALLY
PROTECTED

NDC: 72484-096-03
*Compare to the active ingredient
of Men's Rogaine ®

roman
HAIR
REGROWTH
TREATMENT

Minoxidil Topical Aerosol
5% (For Men)

Reactivates hair follicles
to stimulate regrowth

Clinically proven to
help regrow hair

Easy-to-use
FOAM

NOT FOR USE BY WOMEN

Unscented
Three Month Supply
Three 60 g (2.11 oz) Cans

#1 DERMATOLOGIST
RECOMMENDED
ACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL - Three 60 g Can Package
MINOXIDIL MENS 
minoxidil aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72484-096
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) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72484-096-033 in 1 PACKAGE05/11/202312/14/2023
160 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20907405/11/202312/14/2023
Labeler - ROMAN HEALTH VENTURES INC. (081317350)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078manufacture(72484-096)

Revised: 12/2023