CLOTRIMAZOLE JOCK ITCH (CLOTRIMAZOLE) CREAM [WAL-MART STORES, INC.]

CLOTRIMAZOLE JOCK ITCH (CLOTRIMAZOLE) CREAM [WAL-MART STORES, INC.]
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NDC 49035-123-07
Set ID 142c53ba-d616-434e-8fce-a79821dd5384
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • cures most jock itch (tinea cruris)
    • for effective relief of
      • itching
      • scaling
      • cracking
      • burning
      • redness
      • soreness
      • irritation
      • discomfort
  • Warnings

    For external use only

    Ask a doctor before use

    • on children under 2 years of age

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 2 weeks (for jock itch)

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    This product is not effective on the scalp or nails.

    For jock itch

    use daily for 2 weeks.

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product
  • Other information

    • unscrew cap, pull tab to remove foil 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?

    1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Wal-Mart Stores, Inc.,
    Bentonville, AR 72716.

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    NDC 49035-123-07

    equate®

    Compare to
    Lotrimin
    ® AF
    Active
    Ingredient*

    Jock Itch
    Clotrimazole USP 1%
    Antifungal Cream

    Cures Most
    Jock Itch

    • Relieves itching, burning,
      scaling and chafing

    NET WT
    0.5 OZ (15 g)

    Principal Display Panel - 15 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE   JOCK ITCH
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-123
    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:49035-123-071 in 1 CARTON
    115 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C08/31/1993
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(49035-123)