Label: RUGBY CLOTRIMAZOLE ANTIFUNGAL CREAM- clotrimazole cream

  • NDC Code(s): 0536-1265-11, 0536-1265-26, 0536-1265-95
  • Packager: Rugby Laboratories
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 14, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Clotrimazole USP 1% w/w

  • Purpose

    Antifungal Cream

  • KEEP OUT OF REACH OF CHILDREN

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

  • 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

    For external use only

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

    ● Avoid contact with eyes.

  • Directions

    • Wash 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 persists longer, consult a doctor.

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

  • Stop Use and ask a doctor if

    • Irritation occurs
    • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
  • Inactive Ingredients

    Dimethyl Sulfoxide, Ethylparaben, Glycerin, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, Water

  • Other Information

    • store at controlled room temperature 15°-30°C (59°- 86°F)
    • Close cap tightly after use.
  • Other Information

    Clotrimazole Antifungal Cream is not manufactured or distributed by Bayer, owners of the registered trademark Lotrimin®AF.

  • Questions

    Keep carton for complete Drug Facts

    Call 1-800-645-2158

    Distributed by:

    RUGBY® LABORATORIES

    17177 N. Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

    Made in China

  • Packaging and Label

    370816 RUGBY CLOTRIMAZOLE CREAM 1 PERCENT 1.6OZ 011722 CDER

  • PRINCIPAL DISPLAY PANEL

    371174 RUGBY CLOTRIMAZOLE CREAM 1 percent 1OZ REV1023 110223 CDER

  • Package Label

    371175 RUGBY CLOTRIMAZOLE CREAM 1 percent 0.5OZ REV1023 110623 CDER

  • INGREDIENTS AND APPEARANCE
    RUGBY CLOTRIMAZOLE ANTIFUNGAL CREAM 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LAURETH-23 (UNII: N72LMW566G)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1265-261 in 1 BOX03/19/2020
    145 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0536-1265-951 in 1 BOX11/20/2023
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0536-1265-111 in 1 BOX11/20/2023
    314.17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/19/2020
    Labeler - Rugby Laboratories (079246066)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)