CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1% SOLUTION [SINCERUS FLORIDA, LLC]

CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1% SOLUTION [SINCERUS FLORIDA, LLC]
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NDC 72934-4045-9
Set ID 87480bb9-e7a7-5ef1-e053-2995a90a0e40
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Sincerus Florida, LLC
Generic Name
Product Class Allylamine Antifungal, Azole Antifungal
Product Number
Application Number
  • Directions for use

    s

  • Sincerus Florida, LLC adverse reactions.

    d

  • Active, inactive

    a

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

    s

  • 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)

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