MINOXIDIL EXTRA STRENGTH FOR MEN- minoxidil solution 
Actavis Pharma, Inc.

----------

Minoxidil Topical Solution for Men

Drug Facts

Active ingredient

Minoxidil, USP 5% w/v

Purpose

Hair regrowth treatment for men

Use

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

Warnings

For external use only. For use by men only.
Flammable: Keep away from fire or flame

Do not use if

  • you are a woman
  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • 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. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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 all men.

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

Other information

Inactive ingredients

alcohol (30% v/v), propylene glycol (50% v/v), 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® Extra Strength*

NDC 0472-0094-73

Extra Strength 
FOR MEN

Minoxidil Topical 
Solution, USP 5%

HAIR REGROWTH 
TREATMENT

Reactivates Hair Follicles
to Stimulate Regrowth

Clinically Proven to
Help Regrow Hair

Unscented

NOT FOR USE BY WOMEN

FOR BEST RESULTS
APPLY DIRECTLY TO SCALP
TWICE DAILY

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

single carton

mens

MINOXIDIL  EXTRA STRENGTH FOR MEN
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-0094
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0472-0094-731 in 1 CARTON11/20/2000
160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:0472-0094-752 in 1 CARTON11/20/2000
260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07551811/20/2000
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 11/2019
Document Id: f109d743-b84f-4da6-869a-826704419432
Set id: b391bd99-46d0-4587-a2cf-177eb09be70e
Version: 12
Effective Time: 20191115
 
Actavis Pharma, Inc.