WESTERN FAMILY ATHLETES FOOT (CLOTRIMAZOLE) CREAM [WESTERN FAMILY FOODS INC]

WESTERN FAMILY ATHLETES FOOT (CLOTRIMAZOLE) CREAM [WESTERN FAMILY FOODS INC]
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NDC 55312-305-01
Set ID 973dfacf-9398-4880-a12a-7c83e4f1c820
Category HUMAN OTC DRUG LABEL
Packager Western Family Foods Inc
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Clotrimazole 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)
    • for effective relief of
      • itching
      • scaling
      • cracking
      • burning
      • redness
      • soreness
      • irritation
      • discomfort
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  • 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 4 weeks (for athlete's foot and ringworm) or 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.

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  • Directions

    This product is not effective on the scalp or nails.

    For athlete's foot and ringworm: use daily for 4 weeks. 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

    For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily

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  • Other information

    • To open: unscrew cap, use the pointed end of cap to puncture seal.
    • store between 2°- 30°C (36° - 86°F)
    • see carton 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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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    Distributed by
    Western Family
    Foods, Inc.
    P.O. Box 4057
    Portland, OR
    97208 U.S.A.

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  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    Athlete's
    Foot Cream

    Clotrimazole Cream USP, 1%
    ANTIFUNGAL CREAM

    Relieves
    Itching, Burning,
    Scaling and Cracking

    NET WT 1/2 OZ (15 g)

    PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY   ATHLETES FOOT
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-305
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55312-305-01 1 in 1 CARTON
    1 15 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 - Western Family Foods Inc (192166072)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(55312-305)
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