Label: CLOTRIMAZOLE 1% ATHLETES FOOT- clotrimazole cream

  • NDC Code(s): 70677-1002-1
  • 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 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot, jock itch and ringworm
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • Warnings

    For external use only

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

    When using this productavoid 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).

    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
    • 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
    • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, 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 833-358-6431

  • SPL UNCLASSIFIED SECTION

    Distributed by:McKesson Corp.,
    via Strategic Sourcing Services LLC.
    Memphis, TN 38141

  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    Foster & Thrive™

    Athlete's Foot Cream

    Clotrimazole Cream USP, 1%
    ANTIFUNGAL

    NET WT 1 OZ (30 g)

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 1%  ATHLETES FOOT
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1002
    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:70677-1002-11 in 1 CARTON06/14/2023
    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 DrugM00506/14/2023
    Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(70677-1002)
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