NDC | 60900-555-10, 60900-555-20, 60900-555-30 |
Set ID | f7d77d71-566f-4b9f-90a7-7a4ae82f567f |
Category | HUMAN OTC DRUG LABEL |
Packager | Empress Hair Products, Ltd. |
Generic Name | |
Product Class | Arteriolar Vasodilator |
Product Number | |
Application Number | ANDA074588 |
- Drug Facts
- Active ingredient
- Purpose
- INDICATIONS & USAGE
- Warnings
-
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
-
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
-
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
- QUESTIONS
-
———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
TreatmentMinoxidil Topical
Solution,
USP 2%
FOR WOMENUnscented
Clinically Proven to
Help Regrow HairRevitalized Hair Follicles
Three Month Supply
3-60 mL (2 fl oz) Bottles -
INGREDIENTS AND APPEARANCE
RE-GRO
minoxidil solutionProduct 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)