Mens Hair Regrowth Treatment

CVS Pharmacy

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Use
• Warnings
  • Do not use if
  • When using this product
  • Stop use and ask a doctor if
• Directions
• Mens Hair Regrowth Treatment Other information
• Inactive ingredients

FULL PRESCRIBING INFORMATION

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

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088
• 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

• part your hair and apply one mL 2 times a day directly onto the scalp in the area of hair thinning/loss
• 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

Mens Hair Regrowth Treatment 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%
• in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% 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

Not For Use By Women:

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

This Package Contains:

• One 60 mL (2 FL OZ) bottle of Minoxidil Topical Solution 5% (one 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.

*This product is not manufactured or distributed by Pfizer Inc. Distributors of Rogaine ^® .

2004395 00940108G1 VC107710

Distributed by:
CVS Pharmacy, Inc.
Woonsocket, RI 02895
©2008 CVS/pharmacy

Made in Canada
#242114

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% has been shown to regrow hair in men with the following degrees of thinning hair or hair loss.

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

CVS® pharmacy
men"s hair regrowth treatment
Unscented
extra strength
5% Minoxidil topical solution

Clinically proven to help regrow hair
Revitalizes hair follicles

NOT FOR USE BY WOMEN

Compare to Men’s Rogaine^® Extra Strength active ingredient*

One Month Supply
1-60 mL (2 fl oz) Bottle