Regoxidine

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SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/w (without propellant)

Purpose

OTC - PURPOSE SECTION

Hair regrowth treatment for men

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have heart disease

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

May be harmful if used when pregnant or breast-feeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

• Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Innovus Pharmaceuticals, Inc.
Englewood, CO 80112

PRINCIPAL DISPLAY PANEL - Three 60 g Can Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57483-530-31

C^•rcle_™

Regoxidine^®

Minoxidil Topical
Aerosol, 5% (For Men)

Hair Regrowth
Treatment

EASY-TO-USE
FOAM

Unscented

Reactivates Hair Follicles to Stimulate Regrowth
Clinically Proven to Help Regrow Hair

#1 Dermatologist Recommended Active Ingredient^†
*Compare to the active ingredient of Men's Rogaine^®

Not For Use by Women

THREE MONTH SUPPLY
THREE 2.11 OZ (60 g) CANS

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• Regoxidine (For Men)
• Minoxidil
• butylated hydroxytoluene
• cetyl alcohol
• anhydrous citric acid
• ALCOHOL
• isobutane
• LACTIC ACID, UNSPECIFIED FORM
• BUTANE
• polysorbate 60
• propane
• WATER
• stearyl alcohol

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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Product history page 1 of 3 · 88 observed states.

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