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

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Minoxidil Spray

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 scalp (vertex only, see picture on side of carton)

3 Bottle Carton

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

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Directions

Prime the sprayer by holding the bottle the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist

Apply one mL with spray (6 sprays) 2 times a day directly onto the scalp in the hair loss area

Using more or more often will not improve restuls

Continued use is necessary to increase and keep your hair regrowth, or hair loss will begind again.

Other information

See hair loss pictures on side of this carton

Before use, read all information on carton and enclosed leaflet

Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men

Keep the carton. It contains important information.

In clinical studies of mostly white men aged 18-45 years with moderate degrees of hairloss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

Store at controlled room temperature 20 to 25C (68 to 77F)

Inactive ingredients Alcohol, propylene glycol, purified water

Questions? 1-424-347-6299 Visit website at ro.co

Distributed by

Roman Health Ventures, Inc.

116 W. 23rd Street, 4th Floor

New York, NY 10011

www.ro.co

NOT FOR USE BY WOMEN:

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

Minoxidil 5% Topical Solution, USP

Minoxidil 5% Topical Solution

is for men who have a general

thinning of hair on the top of

the scalp vertex only, as

shown below. Not intended

for frontabl baldness or a

receding hairline. Minoxidil

Topical Solution 5% has been

shown to regrow hair in men

with the following degrees of

thinning hair or hairloss.

If men have more hair loss or hair loss in

a place different than showing above, Minoxidil

Topical Solution 5% for men may not work.

For best results:

Apply direclty to scalp. Use twice daily.

Three Bottle Package

NDC xxxxx-xxx-xx

roman

HAIR

REGROWTH

TREATMENT

5% Minoxidil Topical Solution, USP

Extra Strength formula for men

Clinically proven to help regrow hair

Reactivates hair follicles to stimulate growth

Easy precision sprayer

Unscented topical solution

Three month supply

3- 60 mL (2 fl oz) bottles

Total 180 mL (6 fl oz)

Not for use by women

3 Bottle

Single Bottle Package

1 bottleNDC XXXXX-XXX-XX

roman

Hair Regrowth Treatment

5% Minoxidil Topical Solution, USP

Extra Strength formula for men

Clinically proven to help regrow hair

Reactivates hair follicales to stimulate regrowth

Easy precision sprayer

Unscented topical solution

One month supply

1 - 60 mL (2 fl oz) bottle

Not for use by women.

MINOXIDIL  EXTRA STRENGTH FOR MEN
minoxidil spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72484-097
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)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72484-097-013 in 1 CARTON01/01/2024
160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC:72484-097-021 in 1 CARTON01/01/2024
260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623901/01/2024
Labeler - Roman Health Ventures Inc. (081317350)

Revised: 9/2023
Document Id: 0551cb89-1a84-b1cf-e063-6294a90abb73
Set id: 03738dd6-a42c-0986-e063-6294a90a1cc0
Version: 2
Effective Time: 20230914
 
Roman Health Ventures Inc.