NDC 57483-101

Apeaz Ultra

Camphor (synthetic), Menthol, And Methyl Salicylate Cream

Apeaz Ultra is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Innovus Pharmaceuticals, Inc.. The primary component is Camphor (synthetic); Menthol; Methyl Salicylate.

• Product ID: 57483-101_deb65546-0905-49f1-9d77-f552913387c5
• NDC: 57483-101
• Product Type: Human Otc Drug
• Proprietary Name: Apeaz Ultra
• Generic Name: Camphor (synthetic), Menthol, And Methyl Salicylate Cream
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-02-05
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Innovus Pharmaceuticals, Inc.
• Substance Name: CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
• Active Ingredient Strength: 4 mg/g; mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 57483-101-01

1 CONTAINER in 1 CARTON (57483-101-01) > 56.7 g in 1 CONTAINER

• Marketing Start Date: 2018-02-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57483-101-01 [57483010101]

Apeaz Ultra CREAM

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-02-05
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CAMPHOR (SYNTHETIC)	4 mg/g

OpenFDA Data

• SPL SET ID: ec93ca9d-ef59-456f-ac08-d50936f70424
• Manufacturer:
  • Innovus Pharmaceuticals, Inc.
• UNII:
  • 5TJD82A1ET
  • L7T10EIP3A
  • LAV5U5022Y
• RxNorm Concept Unique ID - RxCUI:
  • 1998770
• UPC Code:
  • 0357483000677

NDC Crossover Matching brand name "Apeaz Ultra" or generic name "Camphor (synthetic), Menthol, And Methyl Salicylate Cream"

NDC	Brand Name	Generic Name
15478-111	Apeaz Ultra	camphor (synthetic), menthol, and methyl salicylate
57483-101	Apeaz Ultra	camphor (synthetic), menthol, and methyl salicylate cream