NDC 57613-009

Prevail-FX One Step

Povidone-iodine And Isopropyl Alcohol

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

Product ID57613-009_7821764c-eea2-43b5-8ec4-cd94370ef8e5
NDC57613-009
Product TypeHuman Otc Drug
Proprietary NamePrevail-FX One Step
Generic NamePovidone-iodine And Isopropyl Alcohol
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date1998-06-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333A
Labeler NameCareFusion 2200 Inc
Substance NamePOVIDONE-IODINE; ISOPROPYL ALCOHOL
Active Ingredient Strength8 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57613-009-40

1 APPLICATOR in 1 POUCH (57613-009-40) > 40 mL in 1 APPLICATOR
Marketing Start Date1998-06-01
Marketing End Date2021-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57613-009-40 [57613000940]

Prevail-FX One Step SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date1998-06-01
Marketing End Date2021-04-30

NDC 57613-009-10 [57613000910]

Prevail-FX One Step SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date1998-06-01
Marketing End Date2011-09-09

Drug Details

Active Ingredients

IngredientStrength
POVIDONE-IODINE8.3 mg/mL

OpenFDA Data

SPL SET ID:39195cf1-3c59-498e-9403-f1889a39e44e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1052729
  • 1052725
  • NDC Crossover Matching brand name "Prevail-FX One Step" or generic name "Povidone-iodine And Isopropyl Alcohol"

    NDCBrand NameGeneric Name
    57613-009Prevail-FX One Steppovidone-iodine and isopropyl alcohol
    52380-0039Aplicare ExCel APPovidone-Iodine and isopropyl alcohol
    68356-120Loris 10% Povidone-Iodine and 70% Isopropyl AlcoholPovidone-Iodine and Isopropyl Alcohol
    68356-121Loris 7.5% Povidone-Iodine and 74% Isopropyl AlcoholPovidone-Iodine and Isopropyl Alcohol

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