Label: ATHLETES FOOT- clotrimazole cream

  • NDC Code(s): 70000-0493-1
  • Packager: Cardinal Health 110,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 January 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole USP 1% w/w

  • Purpose

    Antifungal Cream

  • Uses

    Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and chafing associated with jock itch.

  • Warnings

    • Do not use on children under 2 years of age unless directed by a doctor.
    • For external use only.
    • Avoid contact with eyes.

    Stop Use and ask a doctor 

    • if irritation occurs or if there is no improvement within two weeks.

    • Keep this and all drugs out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    <This product is not effective on the scalp or nails.

    • Clean the affected area and dry thoroughly.
    • Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.
    • Supervise children in the use of this product.
    • use daily for 2 weeks.
    • If conditions persists longer, consult a doctor.>
  • Other information

    • Store at controlled room temperature 20°-25°C (68°-77°F).
    • Close cap tightly after use.
  • Inactive ingredients

    aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

  • Questions?

    For Questions or comments or to report an undesired reaction or side effect, please call 1-800-222-1222

  • Principal Display Panel – 1 oz. Tube

    Leader       NDC 70000-0493-1

    CLOTRIMAZOLE 1%

    ANTI-FUNGAL CREAM

     Cures Most Athlete's Foot NET WT. 0.5oz ( 14.2 g)

    Compare to Lotramin

    Principal Display Panel – 0.5 oz. Tube

  • Principal Display Panel – 0.5 oz. Carton

    Leader         NDC 70000-0493-1

    Cures Most

    Athlete's Foot

    Relieves Itching, Burning, Scaling, Discomfort and Chafing

    CLOTRIMAZOLE 1% ANTI-FUNGAL CREAM

    *Compare To the active ingredient in Lotrimin-AF®

    NET WT. 0.5oz (14.2g)

    Principal Display Panel – 0.5 oz. Carton

    Principal Display Panel – 0.5 oz. Carton
  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0493
    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
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0493-11 in 1 CARTON05/15/2019
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/15/2019
    Labeler - Cardinal Health 110,Inc. (063997360)
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