NDC 43553-0000

Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules

Poloxamer 188

Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Convatec Inc. The primary component is Poloxamer 188.

• Product ID: 43553-0000_60dfeda0-e751-1762-e053-2a91aa0a7380
• NDC: 43553-0000
• Product Type: Human Otc Drug
• Proprietary Name: Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules
• Generic Name: Poloxamer 188
• Dosage Form: Liquid
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-10-26
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part333A
• Labeler Name: ConvaTec Inc
• Substance Name: POLOXAMER 188
• Active Ingredient Strength: 200 mg/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 43553-0000-0

24 BOTTLE, UNIT-DOSE in 1 CARTON (43553-0000-0) > 20 mL in 1 BOTTLE, UNIT-DOSE

• Marketing Start Date: 2017-10-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43553-0000-0 [43553000000]

Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-10-26

Drug Details

Active Ingredients

Ingredient	Strength
POLOXAMER 188	200 mg/mL

OpenFDA Data

• SPL SET ID: b2fcc0ef-21a4-48ce-9536-b40e13ff8df9
• Manufacturer:
  • ConvaTec Inc
• UNII:
  • LQA7B6G8JG
• RxNorm Concept Unique ID - RxCUI:
  • 1986876
  • 1986881
• UPC Code:
  • 0768455108916

NDC Crossover Matching brand name "Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules" or generic name "Poloxamer 188"

NDC	Brand Name	Generic Name
43553-0000	Shur Clens Skin Wound Cleanser 24 Count Single Dose Ampules	POLOXAMER 188
68991-003	Cybercy Mayer /Kang Du Qing	POLOXAMER 188
68991-001	KANG DU QING	POLOXAMER 188
68991-002	Mayer /Kang Du Qing	POLOXAMER 188