FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4%- fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4% 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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FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4%

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

FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4% 
fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4% solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-4176
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 2 g  in 100 g
ITRACONAZOLE (UNII: 304NUG5GF4) (ITRACONAZOLE - UNII:304NUG5GF4) ITRACONAZOLE 1 g  in 100 g
TERBINAFINE (UNII: G7RIW8S0XP) (TERBINAFINE - UNII:G7RIW8S0XP) TERBINAFINE 4 g  in 100 g
FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY) FLUCONAZOLE 4 g  in 100 g
Product Characteristics
Color white (CLEAR SOLUTION) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:72934-4176-9 15 g in 1 VIAL, GLASS; Type 0: Not a Combination Product 05/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
Name Address ID/FEI Business Operations
Sincerus Florida, LLC 080105003 manufacture(72934-4176)

Revised: 4/2019
Document Id: 87480522-a42d-5023-e053-2995a90afd30
Set id: 87480522-a42c-5023-e053-2995a90afd30
Version: 1
Effective Time: 20190424
 
Sincerus Florida, LLC