Label: MINOXIDIL REGULAR STRENGTH FOR MEN- minoxidil solution
- NDC Code(s): 71205-490-02
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0472-0066
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 1, 2020
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredient
For external use only
Flammable: Keep away from fire or flame
Do not use if
- your degree of hair loss is different than that shown on the side of this carton, because this product 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
When using this product
- do not apply on other parts of the body
- avoid contact with the eyes. In case of accidental contact, rinse eyes 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
- see hair loss pictures on side of this carton
- before use, read all information on carton and enclosed leaflet
- keep the carton. It contains important information.
- in clinical studies of mostly white men aged 18 to 49 years with moderate degrees of hair loss, the following response to minoxidil topical solution 2% for men was reported: 26% of men reported moderate to dense hair regrowth after using minoxidil topical solution 2% for men for 4 months (26% had moderate to dense regrowth; 33% had minimal regrowth). This compares with 11% of men reporting hair regrowth after using the placebo, the liquid without minoxidil in it, for 4 months (11% had moderate to dense regrowth; 31% had minimal regrowth).
- store at controlled room temperature 20° to 25°C (68° to 77°F).
- Inactive ingredients
Principal Display Panel
Compare to the active ingredient in Men’s Rogaine®*
Solution, USP 2%
Reactivates Hair Follicles
to Stimulate Regrowth
Clinically Proven to
Help Regrow Hair
FOR BEST RESULTS
APPLY DIRECTLY TO SCALP
TWO MONTH SUPPLY
Two 60 mL (2 fl oz) Bottles
INGREDIENTS AND APPEARANCE
MINOXIDIL REGULAR STRENGTH FOR MEN
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-490(NDC:0472-0066) 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:71205-490-02 2 in 1 CARTON 10/19/2020 1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074588 04/05/1996 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-490) , RELABEL(71205-490)