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Hair Regrowth Treatment for Women (Premier Value)

Available Formats

Dosage Form Package Information Links
SOLUTION 2 BOTTLE in 1 CARTON (68016-006-64) > 60 mL in 1 BOTTLE Label Information

Complete Hair Regrowth Treatment for Women Information

  • Drug Facts


  • Active ingredient

    Minoxidil, USP 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 leaflet
    • keep the carton. It contains important information.
    • in clinical studies of mostly white women aged 18 to 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 (60% v/v), propylene glycol, purified water


  • Questions?

    1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.


  • Principal Display Panel

    Premier Value®

    COMPARE TO THE ACTIVE INGREDIENT IN WOMEN’S ROGAINE®*

    For Women
    Minoxidil
    TOPICAL SOLUTION, USP 2%
    HAIR REGROWTH TREATMENT

    Reactivates Hair Follicles
    to stimulate regrowth

    Clinically Proven to
    Help Regrow Hair

    Unscented

    FOR BEST RESULTS
    APPLY DIRECTLY TO SCALP
    TWICE DAILY

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED

    Two Month Supply
    Two 60 mL (2 fl oz) Bottles

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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:68016-006
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68016-006-64 2 in 1 CARTON 01/01/2000
    1 60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074588 01/01/2000
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Teva Pharmaceuticals USA, Inc. (001627975)