MENS KIRKLAND (MINOXIDIL) SOLUTION [COSTCO WHOLESALE CORPORATION]

MENS KIRKLAND (MINOXIDIL) SOLUTION [COSTCO WHOLESALE CORPORATION]
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NDC 63981-111-01
Set ID ee71efe1-2505-4e9e-b1aa-ae8b6463596b
Category HUMAN OTC DRUG LABEL
Packager Costco Wholesale Corporation
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number NDA020834
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Minoxidil 5% w/v

  • Purpose

    Hair regrowth treatment for men

  • Use

    to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

  • Warnings

    For external use only. For use by men only.

    Flammable: Keep away from fire or flame

    Do not use if

    • you are a woman
    • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline.
    • you have no family history of hair loss
    • your hair loss is sudden and/or patchy
    • 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. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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 all men.

    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.
    • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
    • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
    • store at controlled room temperature 20° to 25° C (68° to 77° F)
  • Inactive ingredients

    alcohol, propylene glycol, purified water

  • Questions?

    • call us at 1-877-907-6424
  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    KIRKLAND
    Signature

    MINOXIDIL
    EXTRA STRENGTH FOR MEN

    5% MINOXIDIL TOPICAL SOLUTION

    HAIR REGROWTH
    TREATMENT

    Regrows
    more hair than
    2% Minoxidil
    Topical Solution

    Results may occur at 2 months

    NOT FOR USE BY WOMEN

    Unscented

    3-60 mL (2 fl oz) Bottles

    Principal Display Panel - 60 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MENS KIRKLAND   EXTRA STRENGTH
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1) Minoxidil50 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:63981-111-0112 in 1 TRAY
    12 in 1 PACKAGE, COMBINATION
    13 in 1 CARTON
    160 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02083407/16/2010
    Labeler - Costco Wholesale Corporation (103391843)

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