PurPrep

Manufacturer
CareFusion 213 LLC | Becton, Dickinson and Company
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:41:28

Label at a glance#

ProductPurPrep
Active ingredientISOPROPYL ALCOHOL, POVIDONE-IODINE
Label structure28 sections

Dosage and administration

use in a well ventilated area do not allow solution to pool; tuck prep towels to absorb solution, and then remove remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the tr...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

BD PurPrep™ 10.5 mL Applicator Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 7.2% w/w

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

Purposes

OTC - PURPOSE SECTION

Antiseptic

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

To reduce risk of fire, PREP CAREFULLY:

  • solution contains alcohol and gives off flammable vapors
  • avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
  • do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
  • do not allow the solution to pool
  • remove wet materials from prep area

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption. Daily use of iodine on newborn infants may increase blood iodine level.
  • on open skin wounds or as a general skin cleanser
  • in the eyes or for prepping mucous membranes
  • on iodine sensitive patients

When using this product

OTC - WHEN USING SECTION

  • use in well ventilated area
  • use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use in a well ventilated area
  • do not allow solution to pool; tuck prep towels to absorb solution, and then remove
  • remove applicator from package; do not touch sponge
  • hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic.
  • wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
  • completely wet the treatment area with antiseptic
  • dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds
  • moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes
  • allow the solution to completely dry(minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away.
  • discard prepping materials, including solution soaked materials. It is not necessary to use the entire amount available.

Other information

OTHER SAFETY INFORMATION

  • store between 15-30 °C (59-86 °F)
  • avoid excessive heat above 40 °C (104 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

BD PurPrep™ 26 mL ApplicatorActive Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 72.5% w/w

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

Purposes

OTC - PURPOSE SECTION

Antiseptic

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

T o reduce risk of fire, PREP CAREFULLY:

  • do not use 26-mL applicator for head and neck surgery
  • solution contains alcohol and gives off flammable vapors.
  • avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
  • do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
  • do not allow the solution to pool
  • remove wet materials from prep area

Do not use

OTC - DO NOT USE SECTION

  • on children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption. Daily use of iodine on newborn infants may increase blood iodine level.
  • on open skin wounds or as a general skin cleanser
  • in the eyes or for prepping mucous membranes
  • on iodine sensitive patients

When using this product

OTC - WHEN USING SECTION

  • use in well ventilated area
  • use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use in a well ventilated area
  • do not allow solution to pool; tuck prep towels to absorb solution, and then remove
  • remove applicator from package; do not touch sponge
  • hold the applicator with the sponge down. Pinch wings only once to activate the ampules and release the antiseptic.
  • wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
  • completely wet the treatment area with antiseptic
  • dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds
  • moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes
  • allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away.
  • discard prepping materials, including solution soaked materials. It is not necessary to use the entire amount available.

Other information

OTHER SAFETY INFORMATION

  • store between 15-30 °C (59-86 °F)
  • avoid excessive heat above 40 °C (104 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

BD PurPrep™ 10.5 mL Applicator Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BD PurPrep™ 10.5 mL Applicator

Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w

Patient Preoperative Skin Preparation

Sterile Solution

Applicator is sterile if package is intact

NDC 54365-014-41

Ref 960110

10.5 mL Package Label10.5 mL Package Label

BD PurPrep™ 10.5 mL Applicator Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BD PurPrep™ 10.5 mL Applicator

Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w

Patient Preoperative Skin Preparation

Sterile Solution

Applicator is sterile if package is intact

NDC 54365-014-41

Ref 960110

Carton LabelCarton Label

BD PurPrep™ 26 mL Applicator Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BD PurPrep™ 26 mL Applicator

Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w

Patient Preoperative Skin Preparation

Sterile Solution

Applicator is sterile if package is intact

NDC 54365-014-42

Ref 960120

26 mL Package Label26 mL Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052725povidone-iodine 8.3 % / isopropyl alcohol 72.5 % Topical SolutionPSN12
1052725isopropyl alcohol 0.725 ML/ML / povidone-iodine 83 MG/ML Topical SolutionSCD12
1052725isopropyl alcohol 72.5 % / povidone-iodine 8.3 % Topical SolutionSY12

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00354365014425GTIN-14: 00354365014425
GTIN-12: 354365014425
UPC-A: 354365014425
EAN-13: 0354365014425
GTIN storage (14 digits): 00354365014425
7-960140_Lidding_Rev_B_26mL_clean.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54365-014-41PurPrep1 in 1 POUCHSPONGE112
54365-014-41PurPrep10.5 mL in 1 APPLICATORSPONGE10.512
54365-014-42PurPrep26 mL in 1 APPLICATORSPONGE2612
54365-014-42PurPrep1 in 1 POUCHSPONGE112

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54365-01454365-014-42, 54365-014-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112024-11-05full-release2026-06-01 00:34:14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PurPrepPOVIDONE IODINE AND ISOPROPYL ALCOHOLCareFusion 213 LLCa1c6e118-7861-c8d0-e053-2995a90aeaaa2025-10-08WarningsExact identifier
ndc (package): 54365-014-41
ndc (package): 54365-014-42
ndc (product): 54365-014
ndc11 (package): 54365001441
ndc11 (package): 54365001442
spl id: 40add5c5-68aa-96f9-e063-6294a90a7282
spl set id: a1c6e118-7861-c8d0-e053-2995a90aeaaa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.