Label: HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil solution

  • NDC Code(s): 59779-856-16, 59779-856-30, 59779-856-34
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 07/09

If you are a consumer or patient please visit this version.

  • Active ingredient

    Minoxidil 2% w/v

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  • Purpose

    Hair regrowth treatment

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  • Uses

    to regrow hair on the scalp

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  • 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.

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  • 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
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  • 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.
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  • Inactive ingredients

    alcohol, propylene glycol, purified water

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  • Questions or comments?

    1-800-719-9260

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  • 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 - Left Side

    Hair Regrowth Treatment for Women Carton - Right Side

    Hair Regrowth Treatment for Women Carton - Right Side

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  • INGREDIENTS AND APPEARANCE
    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 (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 2 g  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-856-16 1 in 1 CARTON
    1 60 mL in 1 BOTTLE
    2 NDC:59779-856-30 3 in 1 CARTON
    2 60 mL in 1 BOTTLE
    3 NDC:59779-856-34 4 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)
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