RE-GRO- minoxidil solution

Re-Gro by

Drug Labeling and Warnings

Re-Gro by is a Otc medication manufactured, distributed, or labeled by Empress Hair Products, Ltd., Contract Pharmaceuticals Limited Canada. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Minoxidil, USP 2% w/v

Purpose

Hair regrowth treatment

INDICATIONS & USAGE

Use to regrow hair on the scalp

Warnings

For external use only
Flammable: Keep away from fire or flame

DO NOT USE

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 DOCTOR

Ask a doctor before use if you have heart disease

WHEN USING

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

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 INGREDIENT

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

QUESTIONS

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

INGREDIENTS AND APPEARANCE

RE-GRO 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60900-555
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	2 g  in 100 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: 60900-555-10	1 in 1 CARTON
1		60 mL in 1 BOTTLE
2	NDC: 60900-555-20	2 in 1 CARTON
2		60 mL in 1 BOTTLE
3	NDC: 60900-555-30	3 in 1 CARTON
3		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074588	04/01/2014

Labeler - Empress Hair Products, Ltd. (175791966)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmaceuticals Limited Canada		248761249	manufacture(60900-555)