WOMENS MINOXIDIL HAIR GROWTH SYSTEM- minoxidil liquid

Womens Minoxidil by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Minoxidil 2% w/v

Purpose

Hair Regrowth for women

Warnings

For external use only.

Flammable: Keep away from fire or flame

Use

To regrow hair on the scalp

WARNINGS

Do not use if

• you have no family history of hair loss
• your hair loss is sudden and/or patchy
• your hair loss is associated with childbirth
• 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

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)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

WOMEN'S
Minoxidil Hair Regrowth

2% MINOXIDIL TOPICAL SOLUTION, USP
HAIR REGROWTH TREATMENT

Unscented

Clinically proven to help regrow hair

Reactivates hair follicles to
stimulate regrowth

Topical Solution

One Month Supply 60 mL (2 fl oz)

Available Custom Branded
800.445.2595
c.service@topixpharm.com

INGREDIENTS AND APPEARANCE

WOMENS MINOXIDIL   HAIR GROWTH SYSTEM
minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	20 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: 51326-161-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078176	03/26/2021

Labeler - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	MANUFACTURE(51326-161)