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Re-Gro

Medically reviewed by Drugs.com. Last updated on Oct 27, 2021.

Dosage form: solution
Ingredients: MINOXIDIL 2g in 100mL
Labeler: Empress Hair Products, Ltd.
NDC Code: 60900-555

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

  • your degree of hair loss is more than that shown on the side of this carton, because this propuct may not work for you
  • 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 with large amounts of cool tap water.
  • some people have experienced changes in hair color and/or texture
  • it takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results.
  • the amount of hair regrowth is different for each person. This product will not work for everyone.

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 or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth in 4 months

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
  • see hair loss pictures on side of this carton
  • before use, read all information on carton and enclosed leaflet
  • keep this carton. It contains important information.
  • in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • store at controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.

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

RE-GRO 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60900-555
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (MINOXIDIL) MINOXIDIL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:60900-555-101 BOTTLE (BOTTLE) in 1 CARTON
160 mL in 1 BOTTLE
2NDC:60900-555-202 BOTTLE (BOTTLE) in 1 CARTON
260 mL in 1 BOTTLE
3NDC:60900-555-303 BOTTLE (BOTTLE) 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/FEIOperations
Contract Pharmaceuticals Limited Canada248761249manufacture(60900-555)

 
Empress Hair Products, Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.