NDC 72934-4176

FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4%

Fluconazole 4% / Ibuprofen 2% / Itraconazole 1% / Terbinafine Hcl 4%

FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4% is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Ibuprofen; Itraconazole; Terbinafine; Fluconazole.

Product ID72934-4176_87480522-a42d-5023-e053-2995a90afd30
NDC72934-4176
Product TypeHuman Prescription Drug
Proprietary NameFLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4%
Generic NameFluconazole 4% / Ibuprofen 2% / Itraconazole 1% / Terbinafine Hcl 4%
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2019-05-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameSincerus Florida, LLC
Substance NameIBUPROFEN; ITRACONAZOLE; TERBINAFINE; FLUCONAZOLE
Active Ingredient Strength2 g/100g; g/100g; g/100g; g/100g
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],Allylamine [CS],Allylamine Antifungal [EPC],Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72934-4176-9

15 g in 1 VIAL, GLASS (72934-4176-9)
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72934-4176-9 [72934417609]

FLUCONAZOLE 4% / IBUPROFEN 2% / ITRACONAZOLE 1% / TERBINAFINE HCL 4% SOLUTION
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-05-01

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN2 g/100g

Pharmacological Class

  • Cyclooxygenase Inhibitors [MoA]
  • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Azole Antifungal [EPC]
  • Azoles [CS]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Breast Cancer Resistance Protein Inhibitors [MoA]
  • Allylamine [CS]
  • Allylamine Antifungal [EPC]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • Cyclooxygenase Inhibitors [MoA]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Azole Antifungal [EPC]
  • Azoles [CS]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Inhibitors [MoA]
  • Breast Cancer Resistance Protein Inhibitors [MoA]
  • Allylamine [CS]
  • Allylamine Antifungal [EPC]
  • Azole Antifungal [EPC]
  • Azoles [CS]
  • Cytochrome P450 2C19 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • Cytochrome P450 2C9 Inhibitors [MoA]

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