Mens Minoxidil

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Minoxidil 5% w/v

Purpose

OTC - PURPOSE SECTION

Hair Regrowth for men

Warnings

WARNINGS SECTION

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Use

INDICATIONS & USAGE SECTION

To regrow hair on the scalp

Do not use if

OTC - DO NOT USE SECTION

• you are a woman
• 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 or 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

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 of redness occurs
• unwanted facial hair growth occurs

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply one mL 2 times a day directly onto the scalp in the hair loss area

• see enclosed leaflet for complete Directions for Use
• using more or more often will not improve result
• continued use is necessary, or hair loss will begin again

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Propylene Glycol, Purified Water

Questions?

OTC - QUESTIONS SECTION

Call Topiderm at 800-445-2595 or reach us on the internet at topiderm.com

STORAGE AND HANDLING SECTION

Store at Controlled Room Temperature 20° to 25°C (68° to 77°F)

SPL UNCLASSIFIED SECTION

Distributed By: Topiderm Inc., 5200 New Horizions Blvd. N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

MEN'S
Minoxidil Hair Regrowth

EXTRA STREGNTH
5% MINOXIDIL
TOPICAL SOLUTION, USP
HAIR REGROWTH TREATMENT

Reactivates Hair Follicles to Stimulate Regrowth
Clinically Proven to Help Regrow Hair
Topical Solution
Unscented

For Best Results:
Apply Directly to Scalp. Use Twice Daily

One Month Supply 60mL (2 fl oz)

Available Custom Branded
800.445.2595
c.service@topixpharm.com

DailyMed Dashboard NDC Coverage#

Products#

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• Mens Minoxidil Hair Growth System
• Minoxidil
• ALCOHOL
• PROPYLENE GLYCOL
• WATER

NDC Codes#

Ingredients#

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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