Label: CAREONE  CLOTRIMAZOLE- clotrimazole cream 

  • NDC Code(s): 41520-305-02
  • Packager: American Sales Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Clotrimazole USP, 1%

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  • Purpose

    Antifungal

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  • 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
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  • 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.

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  • 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-fitted, 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
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  • Other information

    • store between 2-30C (36-86F)
    • do not use if seal on tube is broken or is not visible
    • see box or tube crimp for lot number and expiration date.
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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    AMERICAN SALES COMPANY
    4201 WALDEN AVENUE
    LANCASTER, NY 14086

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  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    ANTIFUNGAL
    CREAM

    CURES MOST ATHLETE'S FOOT
    CLOTRIMAZOLE CREAM USP, 1%
    Relieves Itching & Burning
    Greaseless, Nonstaining

    NET WT 30 g (1 OZ)

    Principal Display Panel - 30 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CAREONE   CLOTRIMAZOLE
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-305
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clotrimazole (Clotrimazole) Clotrimazole 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    benzyl alcohol  
    cetostearyl alcohol  
    cetyl esters wax  
    octyldodecanol  
    polysorbate 60  
    water  
    sorbitan monostearate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-305-02 1 in 1 CARTON
    1 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 08/31/1993
    Labeler - American Sales Company (809183973)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(41520-305)
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