NDC 58133-055

BerbereX Wound Cleanser

Allantoin, Benzethonium Chloride

BerbereX Wound Cleanser is a Topical Solution in the Human Otc Drug category. It is labeled and distributed by Cosmetic Specialty Labs, Inc.. The primary component is Allantoin; Benzethonium Chloride.

• Product ID: 58133-055_1d8d9dbb-4554-49ea-98ea-d63e508f34fd
• NDC: 58133-055
• Product Type: Human Otc Drug
• Proprietary Name: BerbereX Wound Cleanser
• Generic Name: Allantoin, Benzethonium Chloride
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-09-15
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part333A
• Labeler Name: Cosmetic Specialty Labs, Inc.
• Substance Name: ALLANTOIN; BENZETHONIUM CHLORIDE
• Active Ingredient Strength: 5 g/1000mL; g/1000mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58133-055-04

118 mL in 1 BOTTLE (58133-055-04)

• Marketing Start Date: 2013-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58133-055-08 [58133005508]

BerbereX Wound Cleanser SOLUTION

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-09-15
• Inactivation Date: 2020-01-31

NDC 58133-055-16 [58133005516]

BerbereX Wound Cleanser SOLUTION

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-09-15
• Inactivation Date: 2020-01-31

NDC 58133-055-04 [58133005504]

BerbereX Wound Cleanser SOLUTION

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-09-15
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ALLANTOIN	5 g/1000mL

OpenFDA Data

• SPL SET ID: cd8c1230-f356-4587-8e49-4c7db6e09849
• Manufacturer:
  • Cosmetic Specialty Labs, Inc.
• UNII:
  • 344S277G0Z
  • PH41D05744
• RxNorm Concept Unique ID - RxCUI:
  • 1487627
  • 1437628
• UPC Code:
  • 0799475062131

NDC Crossover Matching brand name "BerbereX Wound Cleanser" or generic name "Allantoin, Benzethonium Chloride"

NDC	Brand Name	Generic Name
52261-0500	BerbereX Wound Cleanser	Benzethonium Chloride
58133-055	BerbereX Wound Cleanser	Allantoin, Benzethonium Chloride
24909-617	Aspiera Wound Care and Antiseptic	Allantoin, Benzethonium Chloride
24909-618	Aspiera Wound Care and Antiseptic	Allantoin, Benzethonium Chloride
24909-131	Terrasil Skin Repair	Allantoin, Benzethonium Chloride
24909-132	Terrasil Skin Repair	Allantoin, Benzethonium Chloride
24909-116	Terrasil Wound Care	Allantoin, Benzethonium Chloride
24909-117	Terrasil Wound Care	Allantoin, Benzethonium Chloride