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Womens Rogaine (Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.)

Available Formats

Dosage Form Package Information Links
SOLUTION 3 BOTTLE, PLASTIC in 1 CARTON (42002-105-06) > 60 mL in 1 BOTTLE, PLASTIC Label Information
SOLUTION 1 BOTTLE, PLASTIC in 1 CARTON (42002-105-02) > 60 mL in 1 BOTTLE, PLASTIC Label Information

Complete Womens Rogaine Information


    Drug Facts

  • Active ingredient

    Minoxidil 2% w/v

  • Purpose

    Hair regrowth treatment

  • Use

    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 booklet
    • 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 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution 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 controlled room temperature 20° to 25° C (68° to 77° F)

  • Inactive ingredients

    alcohol, propylene glycol, purified water

  • Questions?

    • call us at 1-800-ROGAINE (1-800-764-2463)
    • visit rogaine.com
    • for more information about hair thinning, visit womenhairinstitute.com

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton




    2% Minoxidil
    Topical Solution

    Hair Regrowth



    Topical Solution


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

    Principal Display Panel - 60 mL Bottle Carton

    minoxidil solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42002-105
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1) Minoxidil 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Alcohol (UNII: 3K9958V90M)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42002-105-02 1 in 1 CARTON 08/01/2010 12/01/2018
    1 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:42002-105-06 3 in 1 CARTON 08/01/2010 12/01/2018
    2 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019501 08/01/2010 12/01/2018
    Labeler - Johnson & Johnson Consumer Inc. (002347102)