Label: RUGBY CLOTRIMAZOLE ANTIFUNGAL CREAM- clotrimazole cream

  • 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 March 18, 2020

If you are a consumer or patient 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

    CDER CAH RGB Clotrimazole Antifungal Cream 1oz

  • 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/19/2020
    Labeler - Rugby Laboratories (079246066)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)