REGEN- 5% minoxidil topical solution solution 
Premium Distribution, LLC

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Drug Facts

Active ingredient

Minoxidil USP 5% w/v

Purpose

Hair regrowth treatment for men

Use

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

Warnings

For external use only.  For use by men only.

Flammable: Keep away from fire or flame

Do not use if

​Ask a doctor before use if you have heart disease

When using this product

Stop use and ask a doctor if

​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

Other information

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

Call your health professional or Follinique at 888-508-0320 Monday - Friday 9:00 AM - 5:00 PM (MST)

Regen by Follinique

Men's 5% Minoxidil Topical Solution, USP

Extra Strength For Men

Hair Regrowth Treatment

Reactivates hair follicles to stimulate regrowth

Clinically proven to help regrow hair

Unscented Topical Solution

Not for use by women

One 60 mL (2 fl oz) Bottle / One month supply

regen

REGEN 
5% minoxidil topical solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70788-580
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:70788-580-011 in 1 CARTON12/01/2016
160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07623912/01/2016
Labeler - Premium Distribution, LLC (079805390)

Revised: 4/2017
Document Id: ab7844b9-fc1f-40da-9992-2c6eda824ee3
Set id: bffed457-967a-4afb-87c9-3e4e1285f04d
Version: 1
Effective Time: 20170427
 
Premium Distribution, LLC