Label: CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1% solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 24, 2019

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  • Directions for use

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  • Sincerus Florida, LLC adverse reactions.

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  • Active, inactive

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  • NDC 72934-4045-9 CICLOPIROX OLAMINE USP 8% / FLUCONAZOLE USP 1% / TERBINAFINE HCL USP 1%. Solution 15gm

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  • INGREDIENTS AND APPEARANCE
    CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1% 
    ciclopirox 8% / fluconazole 1% / terbinafine hcl 1% solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-4045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ) CICLOPIROX8 g  in 100 g
    FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY) FLUCONAZOLE1 g  in 100 g
    TERBINAFINE (UNII: G7RIW8S0XP) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE1 g  in 100 g
    Product Characteristics
    Colorwhite (CLEAR SOLUTION) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-4045-915 g in 1 VIAL, GLASS; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2019
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003manufacture(72934-4045)