NDC 72934-7133

KETOCONAZOLE 2% / SALICYLIC ACID 2%

Ketoconazole 2% / Salicylic Acid 2%

KETOCONAZOLE 2% / SALICYLIC ACID 2% is a Topical Shampoo in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Salicylic Acid; Ketoconazole.

• Product ID: 72934-7133_89062fdd-eed3-022a-e053-2995a90a53da
• NDC: 72934-7133
• Product Type: Human Prescription Drug
• Proprietary Name: KETOCONAZOLE 2% / SALICYLIC ACID 2%
• Generic Name: Ketoconazole 2% / Salicylic Acid 2%
• Dosage Form: Shampoo
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-05-17
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Sincerus Florida, LLC
• Substance Name: SALICYLIC ACID; KETOCONAZOLE
• Active Ingredient Strength: 2 g/100g; g/100g
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72934-7133-6

120 g in 1 CYLINDER (72934-7133-6)

• Marketing Start Date: 2019-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72934-7133-6 [72934713306]

KETOCONAZOLE 2% / SALICYLIC ACID 2% SHAMPOO

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
SALICYLIC ACID	2 g/100g

OpenFDA Data

• SPL SET ID: 89062fdd-eed2-022a-e053-2995a90a53da
• Manufacturer:
  • Sincerus Florida, LLC
• UNII:
  • O414PZ4LPZ
  • R9400W927I

Pharmacological Class

• Azole Antifungal [EPC]
• Azoles [CS]
• Cytochrome P450 3A4 Inhibitors [MoA]
• Cytochrome P450 3A5 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Azole Antifungal [EPC]
• Azoles [CS]
• Cytochrome P450 3A4 Inhibitors [MoA]
• Cytochrome P450 3A5 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]