Label: KERANIQUE FOR WOMEN HAIR REGROWTH TREATMENT- minoxidil liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 10, 2017

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

  • KERANIQUE For Women Hair Regrowth Treatment
  • Active ingredient

    Minoxidil 2% w/v

    Purpose

    Hair regrowth treatment

    Close
  • Use

    to regrow hair on the scalp

    Close
  • 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 hand 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.

    Close
  • 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
    Close
  • 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 solutions 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 USP controlled room temperature 20 o - 25 oC. (68 o - 77 oF). Keep tightly closed.
    Close
  • Inactive ingredients

    alcohol, propylene glycol, purified water

    Close
  • Questions or comments?

    1-888-237-4131

    Close
  • KERANIQUE For Women Hair Regrowth Treatment 2-60ml (65121-562-02)
  • INGREDIENTS AND APPEARANCE
    KERANIQUE FOR WOMEN HAIR REGROWTH TREATMENT 
    minoxidil liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65121-562
    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)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65121-562-02 1 in 1 CARTON 02/10/2017
    1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078176 02/06/2014
    Labeler - Pure Source, LLC (080354456)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source, LLC 080354456 manufacture(65121-562) , repack(65121-562)
    Close