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Hair Regrowth Treatment by Actavis Pharma, Inc.

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


Hair regrowth treatment


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


For external use only
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.

  • 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


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

Principal Display Panel


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

NDC 0472-0066-73

Regular Strength
Minoxidil Topical
Solution, USP 2%


Reactivates Hair Follicles
to Stimulate Regrowth

Clinically Proven to
Help Regrow Hair




One 60 mL (2 fl oz) Bottle

Hair regrowth treatment for men

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
Inactive Ingredients
Ingredient NameStrength
#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
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 11/2017
Actavis Pharma, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.