NDC 54365-014

PurPrep

Povidone Iodine And Isopropyl Alcohol

PurPrep is a Topical Sponge in the Human Otc Drug category. It is labeled and distributed by Carefusion 213 Llc. The primary component is Povidone-iodine; Isopropyl Alcohol.

Product ID54365-014_a1c6e118-7862-c8d0-e053-2995a90aeaaa
NDC54365-014
Product TypeHuman Otc Drug
Proprietary NamePurPrep
Generic NamePovidone Iodine And Isopropyl Alcohol
Dosage FormSponge
Route of AdministrationTOPICAL
Marketing Start Date2020-04-09
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333A
Labeler NameCareFusion 213 LLC
Substance NamePOVIDONE-IODINE; ISOPROPYL ALCOHOL
Active Ingredient Strength8 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 54365-014-42

1 APPLICATOR in 1 POUCH (54365-014-42) > 26 mL in 1 APPLICATOR
Marketing Start Date2020-04-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54365-014-42 [54365001442]

PurPrep SPONGE
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-09

Drug Details

Active Ingredients

IngredientStrength
POVIDONE-IODINE8.3 mg/mL

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