MENS MINOXIDIL  HAIR GROWTH SYSTEM- minoxidil solution 
Topiderm, Inc.

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Men's Minoxidil
Hair Growth System

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

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions?

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

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

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

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
MENS MINOXIDIL   HAIR GROWTH SYSTEM
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51326-160-1660 mL in 1 BOTTLE; Type 0: Not a Combination Product03/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623903/23/2021
Labeler - Topiderm, Inc. (049121643)
Establishment
NameAddressID/FEIBusiness Operations
Topix Pharmaceuticals Inc613171433PACK(51326-160)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456MANUFACTURE(51326-160)

Revised: 4/2021
Document Id: 86526a3a-3bf7-446b-b419-feb41461a979
Set id: 18547d9b-6786-426d-b98d-d70ea0f5becd
Version: 2
Effective Time: 20210423
 
Topiderm, Inc.