PURPREP- povidone iodine and isopropyl alcohol sponge 
CareFusion 213 LLC

----------

PurPrep

Isopropyl alcohol 72.5% w/w

Povidone-iodine 8.3% w/w (0.83% available iodine)

Antiseptic

Antiseptic

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

For external use only. Flammable, keep away from fire or flame.

T o reduce risk of fire, PREP CAREFULLY:

Do not use

When using this product

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These maybe signs of a serious condition.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Acrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water

Questions? call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

7-960140 lidding

7-960170_10.5mL

PURPREP 
povidone iodine and isopropyl alcohol sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL725 mg  in 1 mL
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE8.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54365-014-421 in 1 POUCH04/09/2020
126 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:54365-014-411 in 1 POUCH05/21/2020
210.5 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)04/09/2020
Labeler - CareFusion 213 LLC (826496312)
Registrant - Becton, Dickinson and Company (832696038)
Establishment
NameAddressID/FEIBusiness Operations
Becton, Dickinson and Company124987988manufacture(54365-014)
Establishment
NameAddressID/FEIBusiness Operations
CareFusion 213 LLC826496312manufacture(54365-014) , pack(54365-014) , label(54365-014) , sterilize(54365-014) , analysis(54365-014)

Revised: 11/2023
Document Id: 0a4ce387-972b-d780-e063-6394a90ad203
Set id: a1c6e118-7861-c8d0-e053-2995a90aeaaa
Version: 10
Effective Time: 20231116
 
CareFusion 213 LLC