Label: SUNMARK CLOTRIMAZOLE- clotrimazole cream

  • NDC Code(s): 49348-279-72
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole USP, 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • effectively relieves itching, cracking, burning and discomfort which can accompany these conditions
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

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

  • Directions

    • for best results, follow directions and continue treatment for length of time indicated
    • to open, use pointed end on cap to puncture seal
    • clean skin with soap and water and dry thoroughly
    • apply a thin layer over affected area morning and evening
    • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • best results in athlete's foot and ringworm are usually obtained with 4 weeks use, and in jock itch, with 2 weeks use. If satisfactory results have not occurred within these times, ask a doctor or pharmacist.
    • children under 12 years of age should be supervised in the use of this product
    • this product is not effective on the scalp or nails
  • Other information

    • store between 2°-30°C (36°-86°F)
    • do not use if seal on tube is broken or is not visible
    • See box 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

  • SPL UNCLASSIFIED SECTION

    Distributed by McKesson
    One Post Street
    San Francisco, CA 94104

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    sunmark

    antifungal cream

    Clotrimazole Cream USP, 1%

    CURES MOST ATHLETE'S FOOT

    NET WT 1 OZ (30 g)

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNMARK CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-279
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-279-721 in 1 CARTON08/31/1993
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00508/31/1993
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(49348-279)