MINOXIDIL REGULAR STRENGTH FOR MEN- minoxidil solution 
Proficient Rx LP

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Minoxidil Topical Solution for Men

Drug Facts

Active ingredient

Minoxidil, USP 2% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

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

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 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

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

apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
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 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

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

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

Principal Display Panel

Actavis

Compare to the active ingredient in Men’s Rogaine®*

NDC 71205-490-02

Regular Strength
FOR MEN
Minoxidil Topical
Solution, USP 2%

HAIR REGROWTH
TREATMENT

Reactivates Hair Follicles
to Stimulate Regrowth

Clinically Proven to
Help Regrow Hair

Unscented

FOR BEST RESULTS

APPLY DIRECTLY TO SCALP
TWICE DAILY

TWO MONTH SUPPLY
Two 60 mL (2 fl oz) Bottles

71205-490-02

Hair regrowth treatment for men

MINOXIDIL  REGULAR STRENGTH FOR MEN
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-490(NDC:0472-0066)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-490-022 in 1 CARTON10/19/2020
160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07458804/05/1996
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(71205-490) , RELABEL(71205-490)

Revised: 10/2020
Document Id: 56da6b01-5580-4adc-b33c-981eaeb4007f
Set id: 56da6b01-5580-4adc-b33c-981eaeb4007f
Version: 1
Effective Time: 20201001
 
Proficient Rx LP