Label: FIFTHPULSE MICONAZOLE NITRATE CREAM 4OZ- miconazole nitrate cream

  • NDC Code(s): 69571-017-01
  • Packager: Front Pharmaceutical PLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 18, 2025

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  • DOSAGE & ADMINISTRATION

    DOSAGE

  • WARNINGS

    warning

  • INACTIVE INGREDIENT

    inactive ingredient

  • INDICATIONS & USAGE

    Indication

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    purpose

  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL

  • INGREDIENTS AND APPEARANCE
    FIFTHPULSE MICONAZOLE NITRATE CREAM 4OZ 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color    Score    
    ShapeSize145mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69571-017-01113.4 g in 1 TUBE; Type 0: Not a Combination Product07/19/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00507/19/2025
    Labeler - Front Pharmaceutical PLC (530897792)
    Registrant - Front Pharmaceutical PLC (530897792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Front Pharmaceutical PLC530897792manufacture(69571-017)