KROGER JOCK ITCH (CLOTRIMAZOLE) CREAM [KROGER COMPANY]

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  • KROGER JOCK ITCH (CLOTRIMAZOLE) CREAM [KROGER COMPANY]

KROGER JOCK ITCH (CLOTRIMAZOLE) CREAM [KROGER COMPANY]
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NDC 30142-510-01
Set ID cc536b67-8b0b-4939-b0fb-9a9e4188c4e5
Category HUMAN OTC DRUG LABEL
Packager Kroger 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 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

    • To open: unscrew cap, use the pointed end of cap to puncture seal.
    • store between 20° - 25°C (68° - 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?

    1-800-632-6900

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY THE KROGER CO.
    CINCINNATI, OHIO 45202

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    COMPARE TO active
    ingredient in
    LOTRIMIN® AF †See back panel

    NDC 30142-510-01

    Kroger®

    Jock Itch
    Cream

    Clotrimazole Cream USP, 1%
    Antifungal Cream

    Cures Most Jock Itch
    Relieves Itching, Burning, Scaling & Chafing

    NET WT .5 OZ (15 g)

    PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    KROGER   JOCK ITCH
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-510
    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:30142-510-011 in 1 CARTON02/13/2013
    115 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 - Kroger Company (006999528)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(30142-510)
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