MINOXIDIL EXTRA STRENGTH FOR MEN- minoxidil solution

Minoxidil by

Drug Labeling and Warnings

Minoxidil by is a Otc medication manufactured, distributed, or labeled by Roman Health Ventures Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Minoxidil, USP 5% w/v

PURPOSE

Purpose

Hair regrowth treatment for men

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

• apply one ml with dropper 2 times a day directly onto the scalp in the hair loss area
• 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 SAFETY INFORMATION

Other information

• 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.
• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men
• In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
• store at controlled room temperature 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT

Inactive ingredients Alcohol, propylene glycol, purified water

QUESTIONS

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

SPL UNCLASSIFIED SECTION

Not For Use By Women: May grow facial hair. May be harmful if used during pregnancy or breast-feeding.

Distributed by: Roman Health Ventures, New York, NY 10003

PRINCIPAL DISPLAY PANEL

NDC: 72484-095-03
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Extra Strength For Men
Minoxidil Topical Solution, USP 5%
HAIR REGROWTH TREATMENT
NOT FOR USE BY WOMEN
Reactivates Hair Follicles to Stimulate Regrowth
Clinically Proven to Help Regrow Hair
For best results: Apply directly to scalp twice daily.
Unscented
One month supply
One 60 mL (2 fl oz) Bottle

INGREDIENTS AND APPEARANCE

MINOXIDIL  EXTRA STRENGTH FOR MEN
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72484-095
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72484-095-03	1 in 1 CARTON	05/08/2020
1		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076239	05/08/2020

Labeler - Roman Health Ventures Inc. (081317350)