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Hair Regrowth Treatment by Actavis Pharma, Inc.

Medically reviewed on November 8, 2017

Dosage form: solution
Ingredients: MINOXIDIL 2g in 100mL
Labeler: Actavis Pharma, Inc.
NDC Code: 0472-0066

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 0472-0066-73

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

ONE MONTH SUPPLY
One 60 mL (2 fl oz) Bottle

Hair regrowth treatment for men

HAIR REGROWTH TREATMENT 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-0066
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (MINOXIDIL) MINOXIDIL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:0472-0066-731 BOTTLE in 1 CARTON
160 mL in 1 BOTTLE
2NDC:0472-0066-752 BOTTLE in 1 CARTON
260 mL in 1 BOTTLE
3NDC:0472-0066-773 BOTTLE in 1 CARTON
360 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07458804/05/1996
Labeler - Actavis Pharma, Inc. (119723554)

 
Actavis Pharma, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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