NDC 72934-1126

IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%

Imiquimod 5% / Levocetirizine Dihydrochloride 1% / Tretinoin 0.05%

IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05% is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Tretinoin; Levocetirizine Dihydrochloride; Imiquimod.

• Product ID: 72934-1126_87395273-37fc-7cef-e053-2991aa0a54c6
• NDC: 72934-1126
• Product Type: Human Prescription Drug
• Proprietary Name: IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%
• Generic Name: Imiquimod 5% / Levocetirizine Dihydrochloride 1% / Tretinoin 0.05%
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-05-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Sincerus Florida, LLC
• Substance Name: TRETINOIN; LEVOCETIRIZINE DIHYDROCHLORIDE; IMIQUIMOD
• Active Ingredient Strength: 0 g/100g; g/100g; g/100g
• Pharm Classes: Retinoid [EPC],Retinoids [CS],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72934-1126-2

30 g in 1 BOTTLE, PUMP (72934-1126-2)

• Marketing Start Date: 2019-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 72934-1126-2 [72934112602]

IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05% GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-05-01

Drug Details

Active Ingredients

Ingredient	Strength
TRETINOIN	.05 g/100g

Pharmacological Class

• Retinoid [EPC]
• Retinoids [CS]
• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]
• Increased Cytokine Activity [PE]
• Increased Cytokine Production [PE]
• Interferon Inducers [MoA]
• Retinoid [EPC]
• Retinoids [CS]
• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]
• Increased Cytokine Activity [PE]
• Increased Cytokine Production [PE]
• Interferon Inducers [MoA]

NDC Crossover Matching brand name "IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%" or generic name "Imiquimod 5% / Levocetirizine Dihydrochloride 1% / Tretinoin 0.05%"

NDC	Brand Name	Generic Name
72934-1011	IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%	IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%
72934-1126	IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%	IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / TRETINOIN 0.05%