HAIR REGROWTH TREATMENT FOR MEN EXTRA STRENGTH- minoxidil solution 
Wal-Mart Stores, Inc.

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Minoxidil Topical Solution USP 5%

Drug Facts

Active ingredient

Minoxidil 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 2 times a day directly onto the scalp in the area of hair thinning or hair loss area
  • spread the liquid evenly over the hair loss area. If you use your fingers, wash hands with soap and warm water immediately.
  • 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.
  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men.
  • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
  • store at controlled room temperature 20° to 25°C (68° to 77°F).  Keep tightly closed.

Inactive ingredients

alcohol (30% v/v), propylene glycol (50% v/v), purified water

Questions?

Call: 1-888-287-1915

Not For Use By Women:

May grow facial hair. May be harmful if used during pregnancy or breast-feeding.

This Package Contains:

·         Three 60 mL (2 FL OZ) bottles of Minoxidil Topical Solution 5% (3 month supply)

·         One child-resistant dropper applicator

·         Information leaflet on how to use and obtain best results

Using the Dropper Applicator:

1. Remove cap by pushing and turning in direction of the arrows on the cap

2. Squeeze the rubber bulb and insert the dropper into the bottle. Release the bulb, allowing the dropper to fill to the 1 mL line. If the level of the solution is above the 1 mL line, squeeze the extra amount back into the bottle.

3. Place the tip near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. To prevent the solution from running off the scalp, apply a small amount at a time.

4. After each use attach the dropper to the bottle to make it child-resistant by turning it clockwise until tightly closed.

00940109H1 VC109331 2004839

Distributed by:

Wal-Mart Stores, Inc.

Bentonville, AR 72716

©Wal-Mart Stores, Inc.

Made in Canada

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Rogaine®.

GN2874.66931

Minoxidil Topical Solution 5% is for men who have a general thinning of hair on the top of the scalp (vertex only, as shown below). Not intended for frontal baldness or a receding hairline. Minoxidil Topical Solution 5% for men has been shown to regrow hair in men with the following degrees of thinning hair or hair loss.

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If men have more hair loss or hair loss in a place different than shown above, Minoxidil Topical Solution 5% for men may not work.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Compare to Rogaine® Extra Strength for Men Active Ingredient*

Extra Strength

Hair Regrowth Treatment For Men

Minoxidil Topical Solution USP 5%

Helps Regrow Hair

  • Revitalizes hair follicles

3 Month Supply

3-2 FL OZ (60 mL) BOTTLES

  NOT FOR USE BY WOMEN

tripleMenEquate
HAIR REGROWTH TREATMENT FOR MEN  EXTRA STRENGTH
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49035-904
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (MINOXIDIL) MINOXIDIL50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-904-763 in 1 CARTON
160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07551805/02/2002
Labeler - Wal-Mart Stores, Inc. (051957769)
Establishment
NameAddressID/FEIBusiness Operations
Actavis Mid Atlantic LLC809515898ANALYSIS(49035-904), LABEL(49035-904), MANUFACTURE(49035-904), PACK(49035-904)

Revised: 12/2013
 
Wal-Mart Stores, Inc.