Label: CLOTRIMAZOLE ANTIFUNGAL- clotrimazole solution

  • NDC Code(s): 69396-143-33
  • Packager: Trifecta Pharmaceuticals USA, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 19, 2024

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  • Active Ingredient

    Clotrimazole USP, 1.0%

  • Purpose

    Antifungal

  • Uses

    Cures most

    • Athlete's foot (tinea pedis)
    • Jock Itch (Tinea Cruris)
    • Ringwork (Tinea corporis)

    Effectively relieves

    • Itching
    • Cracking
    • Burning

    Discomfort that can accompany these conditions

  • Warnings

    For External Use Only

  • Stop use and ask a doctor

    • If irritation occurs
    • If there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
  • Ask a Doctor before use

    Ask a doctor before use on children under 2 years of age

  • When using this product

    Avoid Contact with Eyes.

  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    • Spray over affected area
    • If bandaged, let dry first
    • Not to be used on children under 12 years of age
  • Other information

    • Store at controlled room temperature 15º-30ºC (59º-86ºF)

  • Inactive Ingredients

    Ethanol, Propylene glycol, purified water

  • Questions or Comments

    Call 1-888-296-9067

  • Distributed By:

    Trifecta Pharmaceuticals USA®

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

    Globe® Clotrimazole anti-fungal solution is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®AF.

  • Packaging

    4310 GLOBE CLOTRIMAZOLE SOLUTION 1 percent 10ML 110723 CDER FILE

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE ANTIFUNGAL 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-143-331 in 1 BOX11/13/2023
    10.01 L in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00511/13/2023
    Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)
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