Label: ANTIFUNGAL- miconazole ointment

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

Drug Label Information

Updated April 28, 2025

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  • ACTIVE INGREDIENT

    Active Ingredient

  • INACTIVE INGREDIENT

    Inactive Ingredient

  • INDICATIONS & USAGE

    Indications and Usage

  • PURPOSE

    OTC Purpose

  • DOSAGE & ADMINISTRATION

    Dosage and Administration

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    OTC Keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    Package label and Principle PanelPackage labelPackage labelPackage labelPackage Label

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    miconazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84722-3060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE (UNII: 7NNO0D7S5M) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    CETEARETH-20 (UNII: YRC528SWUY)  
    SODIUM CETEARYL SULFATE (UNII: 7ZBS06BH4B)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    IMIDAZOLIDINYL UREA (UNII: M629807ATL)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84722-3060-01 g in 1 TUBE; Type 0: Not a Combination Product04/28/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00504/28/2025
    Labeler - VIVE HEALTH LLC (047025993)