NDC 57613-008

Prevail One Step

Povidone-iodine And Alcohol

Prevail One Step is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Carefusion 2200 Inc. The primary component is Povidone-iodine; Alcohol.

• Product ID: 57613-008_73b76213-2d7c-44db-82d3-6e7649566c6e
• NDC: 57613-008
• Product Type: Human Otc Drug
• Proprietary Name: Prevail One Step
• Generic Name: Povidone-iodine And Alcohol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 1997-06-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part333A
• Labeler Name: CareFusion 2200 Inc
• Substance Name: POVIDONE-IODINE; ALCOHOL
• Active Ingredient Strength: 5 mg/mL; mL/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 57613-008-59

1 APPLICATOR in 1 POUCH (57613-008-59) > 59 mL in 1 APPLICATOR

• Marketing Start Date: 1997-06-01
• Marketing End Date: 2021-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57613-008-59 [57613000859]

Prevail One Step GEL

• Marketing Category: OTC monograph not final
• Application Number: part333A
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 1997-06-01
• Marketing End Date: 2021-04-30

Drug Details

Active Ingredients

Ingredient	Strength
POVIDONE-IODINE	5 mg/mL

OpenFDA Data

• SPL SET ID: f2de3d0e-4887-41b2-9648-568979bb5cc1
• Manufacturer:
  • CareFusion 2200 Inc
• UNII:
  • 85H0HZU99M
  • 3K9958V90M
• RxNorm Concept Unique ID - RxCUI:
  • 1098219
  • 1098215