Label: DR SHEFFIELD ATHLETES FOOT- clotrimazole cream

  • NDC Code(s): 11527-071-15, 11527-071-30, 11527-071-40, 11527-071-51
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1 %

  • Purpose

    Antifungal Cream

  • Uses

    Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

  • Warnings

    • Do not use on children under 2 years of age unless directed by a doctor.
    • For external use only.
    • Avoid contact with eyes.
    • If irritation occurs or if there is not improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

    • Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
  • Directions

    • 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.
    • For athlete's foot, pay special attention to the 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 conditions persist longer, consult a doctor.
    • This product is not effective on the scalp or nails.
  • Other information

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

    Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetyl Esters, Octyldodecanol, Polysorbate 60, Sorbitan Monostearate, Tocopheryl Acetate, Purified Water.

  • Questions

    1-800-222-1087

  • Principal Display Panel – 15g Tube

    Principal Display Panel – 15g Tube

    Sheffield NDC 11524-071-15

    Athlete's
    Foot Cream

    Antifungal Cream

    Clotrimazole 1%

    Helps cure: • Athlete's Foot • Jock Itch • Ringworm

    Made in the USA

    NET WT. 15g (0.52oz)

    Principal Display Panel – 15g Tube

  • Principal Display Panel – 15g Carton

    Principal Display Panel – 15g oz Carton

    Sheffield NDC 11524-071-15

    Athlete's
    Foot Cream

    Antifungal Cream

    Clotrimazole 1%

    Helps cure: • Athlete's Foot • Jock Itch • Ringworm

    Made in the USA

    NET WT. 15g (0.52oz)

    Principal Display Panel – 15g Carton

  • INGREDIENTS AND APPEARANCE
    DR SHEFFIELD ATHLETES FOOT 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-071
    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:11527-071-401 in 1 CARTON10/04/2004
    135.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11527-071-151 in 1 CARTON12/22/2020
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:11527-071-301 in 1 CARTON12/22/2020
    330 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:11527-071-511 in 1 CARTON02/17/2009
    414 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/04/2004
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-071)
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