MENS MINOXIDIL HAIR GROWTH SYSTEM- minoxidil solution

Mens Minoxidil by

Drug Labeling and Warnings

Mens Minoxidil by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc., Topix Pharmaceuticals Inc, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Minoxidil 5% w/v

Purpose

Hair Regrowth for men

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Use

To regrow hair on the scalp

Do not use if

• 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

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

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 of redness occurs
• unwanted facial hair growth occurs

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

Directions

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

Alcohol, Propylene Glycol, Purified Water

Questions?

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

STORAGE AND HANDLING

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

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

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

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

INGREDIENTS AND APPEARANCE

MENS MINOXIDIL   HAIR GROWTH SYSTEM
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-160
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 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: 51326-160-16	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076239	03/23/2021

Labeler - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topix Pharmaceuticals Inc		613171433	PACK(51326-160)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	MANUFACTURE(51326-160)