MINOXIDIL EXTRA STRENGTH FOR MEN- minoxidil solution 
Roman Health Ventures Inc.

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Minoxidil Topical Solution for Men

Drug Facts

1 Bottle Carton

Active ingredient

Minoxidil, USP 5% w/v

3 Bottle Carton

Active ingredient

Minoxidil 5% w/v

1 Bottle Carton

Purpose

Hair regrowth treatment for men

3 Bottle Carton

Purpose

Hair regrowth treatment

1 Bottle Carton

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

3 Bottle Carton

Use to regrow hair on the scalp

Warnings

For external use only. For use by men only.
Flammable: Keep away from fire or flame

Do not use if

  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 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

Ask a doctor before use if you have heart 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.

Directions

Other information

Inactive ingredients Alcohol, propylene glycol, purified water

Questions? 1-424-347-6299 between 9:30 am and 9:00 pm EST, Monday–Friday.

Distributed by

Roman Health Ventures, Inc.

116 W. 23rd Street, 4th Floor

New York, NY 10011

getroman.com

NOT FOR USE BY WOMEN:

May grow facial hair. May be harmful if used during pregnancy or breast-feeding.

For best results, apply directly to scalp twice daily.

Minoxidil Topical Solution USP 5% is for men who have a general thinning of the hair on the top of the scalp (vertex only as shown below). Not intended for frontal baldness or a receding hairline. Minoxidil Topical Solution 5% for men has been shown to regrow hair in men with the following degrees of thinning hair or hair loss.

Minoxidil Baldness Graphic

Single Bottle Package

NDC 72484-095-03
Men's Extra Strength

HAIR REGROWTH TREATMENT

roman MINOXIDIL TOPICAL SOLUTION USP 5%
Reactivates hair follicles to stimulate regrowth
Clinically proven to help regrow hair

NOT FOR USE BY WOMEN
Unscented Topical Solution
One month supply

One 60 mL (2 fl oz) Bottle

72484-095-03 Minoxidil Retail

Three bottle package

NDC 72484-095-06

Men's Extra Strength

HAIR REGROWTH TREATMENT

roman

MINOXIDIL TOPICAL SOLUTION USP 5%

Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

NOT FOR USE BY WOMEN

Unscented Topical Solution

Three month supply

Three 60 mL (2 fl oz) bottles

72484-095-06

MINOXIDIL  EXTRA STRENGTH FOR MEN
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72484-095
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72484-095-031 in 1 CARTON05/08/2020
160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:72484-095-063 in 1 CARTON05/19/2021
260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623905/08/2020
Labeler - Roman Health Ventures Inc. (081317350)

Revised: 6/2023
Document Id: fdb47a5e-80c9-8b0f-e053-6394a90a2668
Set id: a568aba1-1016-4380-e053-2a95a90a396d
Version: 4
Effective Time: 20230609
 
Roman Health Ventures Inc.