CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%- ciclopirox 8% / fluconazole 1% / terbinafine hcl 1% solution 
Sincerus Florida, LLC

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.

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CICLOPIROX 8% / FLUCONAZOLE 1% / TERBINAFINE HCL 1%

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

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)

Revised: 4/2019
Document Id: 87480bb9-e7a8-5ef1-e053-2995a90a0e40
Set id: 87480bb9-e7a7-5ef1-e053-2995a90a0e40
Version: 1
Effective Time: 20190424
 
Sincerus Florida, LLC