NDC 72934-1047

CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17%

Cimetidine 5% / Ibuprofen 2% / Salicylic Acid 17%

CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17% is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Sincerus Florida, Llc. The primary component is Ibuprofen; Cimetidine; Salicylic Acid.

• Product ID: 72934-1047_891a69a7-e005-c8c5-e053-2995a90ab49e
• NDC: 72934-1047
• Product Type: Human Prescription Drug
• Proprietary Name: CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17%
• Generic Name: Cimetidine 5% / Ibuprofen 2% / Salicylic Acid 17%
• Dosage Form: Gel
• 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: IBUPROFEN; CIMETIDINE; SALICYLIC ACID
• Active Ingredient Strength: 2 g/100g; g/100g; g/100g
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 72934-1047-2

30 g in 1 BOTTLE, PUMP (72934-1047-2)

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

NDC SPL Data Element Entries

NDC 72934-1047-2 [72934104702]

CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17% GEL

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

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	2 g/100g

OpenFDA Data

• SPL SET ID: 891a69a7-e004-c8c5-e053-2995a90ab49e
• Manufacturer:
  • Sincerus Florida, LLC
• UNII:
  • O414PZ4LPZ
  • WK2XYI10QM
  • 80061L1WGD
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Histamine H2 Receptor Antagonists [MoA]
• Histamine-2 Receptor Antagonist [EPC]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Cyclooxygenase Inhibitors [MoA]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Histamine H2 Receptor Antagonists [MoA]
• Histamine-2 Receptor Antagonist [EPC]