NDC 72934-2044

CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%

Ciclopirox 3% / Itraconazole 5% / Urea 20%

CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20% is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Ciclopirox Olamine; Itraconazole; Urea.

• Product ID: 72934-2044_8956c20e-0269-317e-e053-2a95a90a486f
• NDC: 72934-2044
• Product Type: Human Prescription Drug
• Proprietary Name: CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20%
• Generic Name: Ciclopirox 3% / Itraconazole 5% / Urea 20%
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-05-20
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Sincerus Florida, LLC
• Substance Name: CICLOPIROX OLAMINE; ITRACONAZOLE; UREA
• Active Ingredient Strength: 3 g/100g; g/100g; g/100g
• Pharm Classes: Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA],Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72934-2044-2

30 g in 1 BOTTLE, PUMP (72934-2044-2)

• Marketing Start Date: 2019-05-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72934-2044-2 [72934204402]

CICLOPIROX 3% / ITRACONAZOLE 5% / UREA 20% CREAM

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-20

Drug Details

Active Ingredients

Ingredient	Strength
CICLOPIROX OLAMINE	3 g/100g

OpenFDA Data

• SPL SET ID: 8956c20e-0268-317e-e053-2a95a90a486f
• Manufacturer:
  • Sincerus Florida, LLC
• UNII:
  • 50MD4SB4AP
  • 304NUG5GF4
  • 8W8T17847W

Pharmacological Class

• Decreased DNA Replication [PE]
• Decreased Protein Synthesis [PE]
• Decreased RNA Replication [PE]
• Protein Synthesis Inhibitors [MoA]
• Azole Antifungal [EPC]
• Azoles [CS]
• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• Decreased DNA Replication [PE]
• Decreased Protein Synthesis [PE]
• Decreased RNA Replication [PE]
• Protein Synthesis Inhibitors [MoA]
• Azole Antifungal [EPC]
• Azoles [CS]
• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]