Hair Regrowth Treatment for Men description, usages, side effects, indications, overdosage, supplying and lots more!

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Hair Regrowth Treatment for Men

ARMY AND AIR FORCE EXCHANGE SERVICE




FULL PRESCRIBING INFORMATION

Drug Facts

Minoxidil 5% w/v

Hair regrowth treatment for men

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

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

  • 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

  • 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.
  • 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 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
  • 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.

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

1-800-432-8534 (select option #2)

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 affiliated with, manufactured by, or produced by the makers or owners of Rogaine ® .

2004805 00940109F1 VC109658

SATISFACTION GUARANTEED OR YOUR MONEY BACK

Manufactured For: Your Military Exchanges
By: Contract Pharmaceuticals Ltd.
7600 Danbro Crescent
0Mississauga, ON Canada L5N 6L6

Made in Canada

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.

Hair Regrowth Treatment for Men

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.

exchange select
Minoxidil Topical Solution USP 5%
EXTRA STRENGTH FOR MEN
HAIR REGROWTH TREATMENT
Compare To The Active Ingredient in Rogaine® Extra Strength For Men*
CLINICALLY PROVEN TO HELP REGROW HAIR
REVITALIZES HAIR FOLLICLES
NOT FOR USE BY WOMEN

ONE MONTH SUPPLY 1-60 mL (2 FL OZ) BOTTLE

Hair Regrowth Treatment for Men

Hair Regrowth Treatment for Men

minoxidil SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55301-094
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
minoxidil MINOXIDIL 50 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
propylene glycol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:55301-094-73 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075518 2007-05-17


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