Label: CLOTRIMAZOLE ATHLETES FOOT- clotrimazole cream

  • NDC Code(s): 49035-812-01, 49035-812-27
  • Packager: Wal-Mart Stores, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 12, 2019

If you are a consumer or patient please visit this version.

  • 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, jock itch and ringworm
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
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  • Warnings

    For external use only

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

    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 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.

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  • 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 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
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  • Other information

    • To open: unscrew cap, use the pointed end of cap to puncture seal.
    • store between 20° - 25°C (68° - 77°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 1-888-287-1915

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716

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  • PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

    NDC 49035-812-01

    equateâ„¢

    Compare to
    Lotrimin® AF
    active
    ingredient*

    Ahtlete's
    Foot

    Clotrimazole USP 1%
    Antifungal Cream

    Cures most
    athlete's foot

    • Relieves itching,
      burning, cracking
      & scaling

    NET WT
    0.5 OZ (14.2 g)

    (CAP THIS END)

    PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE   ATHLETES FOOT
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-812
    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)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-812-01 1 in 1 CARTON 08/31/1993
    1 15 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:49035-812-27 1 in 1 CARTON 08/31/1993
    2 60 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 08/31/1993
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49035-812)
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