FDA Label for Re-gro
View Indications, Usage & Precautions
Re-gro Product Label
The following document was submitted to the FDA by the labeler of this product Empress Hair Products, Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Otc - 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
Otc - Ask Doctor
Ask a doctor before use if you have heart disease
Otc - 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.
Otc - 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
Otc - Keep Out Of Reach Of Children
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
Otc - 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
* Please review the disclaimer below.