Good Sense Hair Regrowth Treatment

Pronunciation

Generic Name: minoxidil
Dosage Form: topical solution

Perrigo Hair Regrowth Treatment Drug Facts

Active ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

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Uses

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

  • 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 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive ingredients

alcohol, propylene glycol, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

Extra Strength

Minoxidil Topical Solution USP, 5%

Hair Regrowth Treatment

For Men

Clinically Proven to Help Regrow Hair

Revitalizes Hair Follicles

Unscented

# Month Supply

Topical Solution

Not for Use by Women

Compare to active ingredient of Men’s Rogaine® Extra Strength

Hair Regrowth Treatment Carton

Good Sense Hair Regrowth Treatment  FOR MEN
minoxidil solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0798
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOXIDIL (MINOXIDIL) MINOXIDIL 3 g  in 60 mL
Product Characteristics
Color YELLOW (Light Amber) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0113-0798-30 1 BOTTLE (BOTTLE) in 1 CARTON
1 60 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075598 12/31/2009
Labeler - L Perrigo Company (006013346)
Revised: 06/2009
 
L Perrigo Company



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