Label: CLOTRIMAZOLE cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • 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

    ● 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 no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

  • 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. 

  • 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.
  • Questions?

    Adverse drug event call 1-888-296-9067
    Dist. By Trifecta Pharmaceuticals USA™
    101 NE Third Avenue, Suite 1500
    Ft. Lauderdale, FL 33301, USA

    Relabeled By: Proficient Rx LP
    Thousand Oaks, CA 91320

  • Packaging

    71205-434-05
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-434(NDC:69396-001)
    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:71205-434-051 in 1 BOX03/18/2020
    114.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/10/2015
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-434) , RELABEL(71205-434)
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