Label: FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4% solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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

If you are a consumer or patient please visit this version.

  • Directions for use

    e

  • Sincerus Florida, LLC adverse reactions.

    d

  • Active, inactive

    q

  • NDC 72934-4176-9 FLUCONAZOLE USP 4% / IBUPROFEN USP 2% / ITRACONAZOLE USP 1% / TERBINAFINE HCL USP 4%. Solution 15gm

    d

  • INGREDIENTS AND APPEARANCE
    FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4% 
    fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4% solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-4176
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN2 g  in 100 g
    ITRACONAZOLE (UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4) ITRACONAZOLE1 g  in 100 g
    TERBINAFINE (UNII: G7RIW8S0XP) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE4 g  in 100 g
    FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY) FLUCONAZOLE4 g  in 100 g
    Product Characteristics
    Colorwhite (CLEAR SOLUTION) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-4176-915 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(72934-4176)