FDA Label for Minoxidil Extra Strength For Men
View Indications, Usage & Precautions
Minoxidil Extra Strength For Men Product Label
The following document was submitted to the FDA by the labeler of this product Roman Health Ventures Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
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.
Otc - Active Ingredient
1 Bottle Carton
Active Ingredient
Minoxidil, USP 5% w/v
3 Bottle Carton
Active Ingredient
Minoxidil 5% w/v
Otc - Purpose
1 Bottle Carton
Purpose
Hair regrowth treatment for men
3 Bottle Carton
Purpose
Hair regrowth treatment
Indications & Usage
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
Warnings
For external use only. For use by men only.
Flammable: Keep away from fire or flame
Dosage & Administration
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 Safety Information
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 Ingredient
Inactive ingredients Alcohol, propylene glycol, purified water
Otc - Questions
Questions? 1-424-347-6299 Visit website at ro.co |
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
Single 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 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.
* Please review the disclaimer below.