REGOXIDINE (FOR MEN)- minoxidil aerosol, foam

Regoxidine by

Drug Labeling and Warnings

Regoxidine by is a Otc medication manufactured, distributed, or labeled by Innovus Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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. (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

SPL UNCLASSIFIED SECTION

Distributed by: Innovus Pharmaceuticals, Inc.
San Diego, CA 92121, USA

PRINCIPAL DISPLAY PANEL - Three 60 g Can Package

*Compare to the active
ingredient of
Men's Rogaine®

NDC: 57483-530-31

FDA Approved

Regoxidine™
Minoxidil
Topical Aerosol,
5% (For Men)

HAIR REGROWTH
TREATMENT

Easy-to-use
foam

UNSCENTED

REVITALIZES
HAIR FOLLICLES

CLINICALLY
PROVEN TO
HELP
REGROW
HAIR

#1 DERMATOLOGIST
RECOMMENDED
ACTIVE INGREDIENT†

Not For Use By Women

Three Month Supply
Three 60 g (2.11 oz) Cans

INGREDIENTS AND APPEARANCE

REGOXIDINE   (FOR MEN)
minoxidil aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-530
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1)	Minoxidil	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (white to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-530-31	3 in 1 PACKAGE	11/12/2019
1		60 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209074	01/02/2019

Labeler - Innovus Pharmaceuticals, Inc. (962507187)