Label: CLOTRIMAZOLE cream

  • NDC Code(s): 69396-001-04, 69396-001-05, 69396-001-09, 69396-001-20, view more
    69396-001-55
  • Packager: TRIFECTA PHARMACEUTICALS USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

If you are a consumer or patient please visit this version.

  • 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 discomfort which can accompany these conditions.

  • Warnings

    For External use only.

  • 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.

  • Do Not Use

    Do not use on children under 2 years of age unless direcgted by a doctor

  • When using this product

    When using this product avoid contact with eyes

  • Stop use and ask doctor if

    • irritaion occurs
    • There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).
  • Keep this and all drugs out of the reach of children

    In case of accidental ingestion, seek professional assistance or contact Poison Control Centre right away.

  • 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.

  • Other Information

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

    Dimethyl Sulfoxide, Ethylparaben, Glycerin, Laureth-23, Mineral Oil, Petrolatum, Water, alcohol, Glyceryl mono and dipalmitostearate, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.

  • 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

  • PRINCIPAL DISPLAY PANEL

    4010 GLOBE CLOTRIMAZOLE CREAM 1OZ LONG HANGING REV06 011023 CDER

  • PRINCIPAL DISPLAY PANEL

    4315 GLOBE CLOTRIMAZOLE CREAM 4OZ 081523 CDER

  • PRINCIPAL DISPLAY PANEL

    4020-FBA-1 GLOBE CLOTRIMAZOLE CREAM 1OZ 5PK BOX 101323 CDER

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    MINERAL OIL (UNII: T5L8T28FGP)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-23 (UNII: N72LMW566G)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-001-555 in 1 BOX11/06/2023
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-001-051 in 1 BOX08/23/2016
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69396-001-09144 in 1 BOX03/09/2022
    30.9 g in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:69396-001-041 in 1 BOX05/03/2022
    4113.4 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:69396-001-201 in 1 BOX03/10/2015
    528.4 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 - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
    Registrant - Trifecta Pharmaceuticals USA (079424163)