Label: FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4% solution
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Contains inactivated NDC Code(s)
NDC Code(s): 72934-4176-9 - Packager: Sincerus Florida, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated April 24, 2019
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- 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
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INGREDIENTS AND APPEARANCE
FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4%
fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4% solutionProduct 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)
