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

Sincerus Florida, LLC adverse reactions.

Active, inactive

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72934-4176-9	15 g in 1 VIAL, GLASS; Type 0: Not a Combination Product	05/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/01/2019

Labeler - Sincerus Florida, LLC (080105003)

Name	Address	ID/FEI	Business Operations
Establishment
Sincerus Florida, LLC		080105003	manufacture(72934-4176)