Hair Regrowth Treatment for Women

Generic Name: minoxidil
Dosage Form: topical solution

CVS Pharmacy, Inc. Hair Regrowth Treatment for Women Drug Facts

Active ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment

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Uses

to regrow hair on the scalp

Warnings

For external use only

Flammable: Keep away from fire or flame

Do not use if

  • your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
  • you have no family history of hair loss
  • your hair loss is sudden and/or patchy
  • your hair loss is associated with childbirth
  • 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. You may need to use this product 2 times a day 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 everyone.

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.
  • in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
  • 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

Hair Regrowth Treatment for Women

Minoxidil Topical Solution USP 2%

Hair Regrowth Treatment

Clinically Proven to Help Regrow Hair

Revitalizes Hair Follicles

Unscented

Compare to Women’s Rogaine® active ingredient

# Month Supply

Hair Regrowth Treatment for Women Carton - Left Side

Hair Regrowth Treatment for Women Carton - Right Side

Hair Regrowth Treatment for Women 
minoxidil solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-856
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINOXIDIL (MINOXIDIL) MINOXIDIL 2 g  in 100 mL
Packaging
# Item Code Package Description
1 NDC:59779-856-16 1 BOTTLE (BOTTLE) in 1 CARTON
1 60 mL in 1 BOTTLE
2 NDC:59779-856-30 3 BOTTLE (BOTTLE) in 1 CARTON
2 60 mL in 1 BOTTLE
3 NDC:59779-856-34 4 BOTTLE (BOTTLE) in 1 CARTON
3 60 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075357 09/08/2006
Labeler - CVS Pharmacy (062312574)
Revised: 07/2009
 
CVS Pharmacy



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