RE-GRO- minoxidil solution 
Empress Hair Products, Ltd.

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Drug Facts

Active ingredient

Minoxidil, USP 2% w/v

Purpose

Hair regrowth treatment

Use to regrow hair on the scalp

Warnings

For external use 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

  • part your hair and apply with dropper one mL 2 times a day directly onto the scalp in the area of hair thinning/loss
  • using more or more often will not improve results
  • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other information

Inactive ingredients alcohol (60% v/v), propylene glycol, purified water

Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

———Package Label.Principal Display Panel———

NDC 60900-555-30

Compare to the active ingredient
in Women's Rogaine®*

EMPRESS®

Re-Gro™ Hair Products for Women of Color

Hair Regrowth
Treatment

Minoxidil Topical
Solution,
USP 2%
FOR WOMEN

Unscented

Clinically Proven to
Help Regrow Hair

Revitalized Hair Follicles

Three Month Supply
3-60 mL (2 fl oz) Bottles

product label
RE-GRO 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60900-555
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60900-555-101 in 1 CARTON
160 mL in 1 BOTTLE
2NDC:60900-555-202 in 1 CARTON
260 mL in 1 BOTTLE
3NDC:60900-555-303 in 1 CARTON
360 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07458804/01/2014
Labeler - Empress Hair Products, Ltd. (175791966)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmaceuticals Limited Canada248761249manufacture(60900-555)

Revised: 11/2014
Document Id: 1fc33789-c0fc-4aa9-b865-2690af27f544
Set id: f7d77d71-566f-4b9f-90a7-7a4ae82f567f
Version: 1
Effective Time: 20141106
 
Empress Hair Products, Ltd.