WALGREENS JOCK ITCH (CLOTRIMAZOLE) CREAM [WALGREEN COMPANY]

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WALGREENS JOCK ITCH (CLOTRIMAZOLE) CREAM [WALGREEN COMPANY]
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NDC 0363-2109-01
Set ID 2d6d7ac8-9f62-4670-9aa2-e73c29034de9
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • cures most jock itch
    • relieves itching, burning, scaling, chafing and discomfort associated with jock itch
  • Warnings

    For external use only

    Do not use on children under 2 years of age unless directed by a doctor.

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 2 weeks

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in the use of this product
    • use daily for 2 weeks
    • if condition persists longer, ask a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE
    • to open: unscrew cap, use the pointed end of cap to puncture seal.
    • store between 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    WALGREEN CO.
    200 WILMOT RD.,
    DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    Walgreens

    Jock Itch Cream

    CLOTRIMAZOLE CREAM USP, 1%
    ANTIFUNGAL
    NET WT 0.5 OZ (14.2 g)

    PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    WALGREENS   JOCK ITCH
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    benzyl alcohol (UNII: LKG8494WBH)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetyl esters wax (UNII: D072FFP9GU)  
    octyldodecanol (UNII: 461N1O614Y)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    water (UNII: 059QF0KO0R)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2109-011 in 1 CARTON09/12/2012
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C08/31/1993
    Labeler - Walgreen Company (008965063)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(0363-2109)
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