HAIR REGROWTH TREATMENT FOR MEN EXTRA STRENGTH- minoxidil solution 
Army and Air Force Exchange Service

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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

• 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

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

NDC 55301-094-73

Compare to the Active Ingredient in Men's Rogaine® Extra Strength*

exchange select

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

quality value

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HAIR REGROWTH TREATMENT FOR MEN  EXTRA STRENGTH
minoxidil solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-094
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 50 mg  in 1 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:55301-094-73 1 in 1 CARTON 05/17/2007
1 60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075518 05/17/2007
Labeler - Army and Air Force Exchange Service (001695568)
Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2017
Document Id: 771ff5f7-f274-4479-ab52-f346eae955c1
Set id: efb8a655-7dab-4518-9570-9dba61914b73
Version: 4
Effective Time: 20171219
 
Army and Air Force Exchange Service