KERANIQUE FOR WOMEN HAIR REGROWTH TREATMENT (MINOXIDIL) LIQUID [PURE SOURCE, LLC]

KERANIQUE FOR WOMEN HAIR REGROWTH TREATMENT (MINOXIDIL) LIQUID [PURE SOURCE, LLC]
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NDC 65121-562-02
Set ID 4ed8ed31-1e37-41a6-bbc4-31c8f1240995
Category HUMAN OTC DRUG LABEL
Packager Pure Source, LLC
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number ANDA078176
  • KERANIQUE For Women Hair Regrowth Treatment


  • 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 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.

  • 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 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.
  • Inactive ingredients

    alcohol, propylene glycol, purified water

  • Questions or comments?

    1-888-237-4131

  • KERANIQUE For Women Hair Regrowth Treatment 2-60ml (65121-562-02)

    Keranique 1Keranique 2

  • INGREDIENTS AND APPEARANCE
    KERANIQUE FOR WOMEN HAIR REGROWTH TREATMENT 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-562
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-562-021 in 1 CARTON02/10/2017
    160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07817602/06/2014
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-562) , repack(65121-562)

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