FDA.reportPublic FDA data

Active Ingredient

Manufacturer
McKesson Medical-Surgical | Degassa
Effective date
2026-07-21
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-07-24 05:10:11

Label at a glance#

ProductMcKesson PVP Prep Solution
Active ingredientPOVIDONE-IODINE
Label structure21 sections

Indications and uses

Health-care antiseptic preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Dosage and administration

Apply product to the operative site prior to surgery Clean the affected area Apply a small amount of this product on the area 1-3 times daily May be covered with a sterile bandage If bandaged, Let dry first

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine, 10% (equivalent to 1% available Iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Health-care antiseptic preparation of the skin prior to surgery.
  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only

Do not

OTC - DO NOT USE SECTION

  • use in the eyes
  • use as a first aid antiseptic Longer than one week
  • use on individuals who are allergic or sensitive to iodine
  • use on deep or puncture wounds
  • use on animal bites
  • use on serious burns
  • apply over Large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions persists or gets worse
  • irritation and redness develop and persists for more than 72 hours

Keep out of the 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

For preparation of the skin prior to surgery

SPL UNCLASSIFIED SECTION

  • Apply product to the operative site prior to surgery

As a first aid antiseptic

SPL UNCLASSIFIED SECTION

  • Clean the affected area
  • Apply a small amount of this product on the area 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, Let dry first

Other Information

OTHER SAFETY INFORMATION

  • Do not store above 77°F (25°C)
  • Do not store below 68°F (20°C)

Not made with natural rubber latex.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Citric Acid, Disodium Phosphate, Glycerin, Purified Water, Sodium Citrate, Tween 80

Principal Display Panel - McKesson PVP Prep Solution 4 fl oz Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

039 each039 eachNDC 68599-3502-1

McKESSON

PVP Prep Solution
MFR# 039


USP 10%

POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

4 fl oz

(118 mL)

Principal Display Panel - McKesson PVP Prep Solution 4 fl oz label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3502-2

McKESSON

PVP Prep Solution USP

10% POVIDONE IODINE

NET CONTENTS

4 fl oz (118 mL)

36 BOTTLES PER CASE

Do not store above 77°F (25°C).

Do not store below 68°F (20°C).

Not made with natural rubber latex.

Distributed By

McKesson Medical-Surgical Inc.

Richmond. VA 23233

PVN B0520 Made in Mexico

LOT

EXP

MFR# 039

039 case039 case

Principal Display Panel - McKesson PVP Prep Solution 16 fl oz Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3500-1

McKESSON

PVP Prep Solution USP
10% POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

16 fl oz

(473 mL)

MFR# 035

035 Each035 Each

Principal Display Panel - McKesson PVP Prep Solution 16 fl oz label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

035 case035 caseNDC 68599-3500-2

McKESSON

PVP Prep Solution USP

10% POVIDONE IODINE

NET CONTENTS

16 fl oz (473 mL)

12 BOTTLES PER CASE

Do not store above 77°F (25°C).

Do not store below 68°F (20°C).

Not made with natural rubber latex.

Distributed By

McKesson Medical-Surgical Inc.

Richmond. VA 23233

PVN B0520 Made in Mexico

LOT

EXP

MFR# 035

Principal Display Panel - McKesson PVP Prep Solution 1 gal Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3500-5

McKESSON

PVP Prep Solution USP

10% POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

1 gal

(3.8 L)

MFR# 036

036 each036 each

Principal Display Panel - McKesson PVP Prep Solution 1 gal label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3500-6

McKESSON

PVP Prep Solution USP

10% POVIDONE IODINE

NET CONTENTS

1 gal (3.8 L)

4 BOTTLES PER CASE

Do not store above 77°F (25°C).

Do not store below 68°F (20°C).

Not made with natural rubber latex.

Distributed By

McKesson Medical-Surgical Inc.

Richmond. VA 23233

PNV B0520 Made in Mexico

LOT

EXP

MFR# 036

036 case036 case

Principal Display Panel - McKesson PVP Prep Solution 8 fl oz. label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3502-5

McKESSON

PVP Prep Solution
USP 10%

POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

8 fl oz

(237 mL)

MFR # 034

034 each034 each

Principal Display Panel - McKesson PVP Prep Solution 8 fl. oz. Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3502-6

McKESSON

PVP Prep Solution USP

10% POVIDONE IODINE

NET CONTENTS

8 fl oz (237 mL)

24 BOTTLES PER CASE

Do not store above 77°F (25°C).

Do not store below 68°F (20°C).

Not made with natural rubber latex.

Distributed By

McKesson Medical-Surgical Inc.

Richmond. VA 23233

PVN B0520 Made in Mexico

LOT

EXP

MFR# 034

034 case034 case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3500-9

MFR # 54W202-1406-909

PVP Prep Pad
10% POVIDONE IODINE PAD
FIRST AID ANTISEPTIC

1406 each1406 each1406 box1406 box1406 case1406 case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3500-3
McKesson MFR # 54W202-7550-909
PVP Solution USP
10% POVIDONE IODINE
FIRST AID ANTISEPTIC
NET CONTENTS 0.75 fl oz (22.2 mL)

7550 each7550 each7550 case7550 case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3500-4
McKesson MFR # 54W202-7510-909
PVP Solution USP
10% POVIDONE IODINE
FIRST AID ANTISEPTIC
NET CONTENTS 0.75 fl oz (22.2 mL)

7510 each7510 each7510 case7510 case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3500-7
McKesson MFR # 307801
PVP Solution USP
10% POVIDONE IODINE
FIRST AID ANTISEPTIC
NET CONTENTS 2 fl oz (59.1 mL)

801 each801 each801 case801 case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-3500-8
McKesson MFR # 307811
PVP Solution USP
10% POVIDONE IODINE SPRAY
FIRST AID ANTISEPTIC
NET CONTENTS 2 fl oz (59.1 mL)

811 each811 each811 each811 each

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130612479214002GTIN-13: 0612479214002
EAN-13: 0612479214002
GTIN-12: 612479214002
UPC-A: 612479214002
GTIN storage (14 digits): 00612479214002		034 each.jpg
BarcodeEAN-130612479281080GTIN-13: 0612479281080
EAN-13: 0612479281080
GTIN-12: 612479281080
UPC-A: 612479281080
GTIN storage (14 digits): 00612479281080		307801 each.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

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
68599-350268599-3502-1, 68599-3502-2, 68599-3502-5, 68599-3502-6
68599-350068599-3500-1, 68599-3500-2, 68599-3500-5, 68599-3500-6, 68599-3500-9, 68599-3500-8, 68599-3500-7, 68599-3500-3, 68599-3500-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE-IODINE85H0HZU99MACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
POLYSORBATE 806OZP39ZG8HIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62026-07-02weekly-update2026-07-17 21:43:37
52024-10-10full-release2026-06-01 00:24:13

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
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsExact identifier
ndc (package): 68599-3502-1
ndc (package): 68599-3500-9
ndc (package): 68599-3500-1
ndc (package): 68599-3500-2
ndc (package): 68599-3502-5
ndc (package): 68599-3500-3
ndc (package): 68599-3500-6
ndc (package): 68599-3500-5
ndc (package): 68599-3500-4
ndc (package): 68599-3502-6
ndc (package): 68599-3500-7
ndc (package): 68599-3502-2
ndc (package): 68599-3500-8
ndc (product): 68599-3500
ndc (product): 68599-3502
ndc11 (package): 68599350009
ndc11 (package): 68599350008
ndc11 (package): 68599350002
ndc11 (package): 68599350001
ndc11 (package): 68599350005
ndc11 (package): 68599350205
ndc11 (package): 68599350003
ndc11 (package): 68599350004
ndc11 (package): 68599350206
ndc11 (package): 68599350006
ndc11 (package): 68599350201
ndc11 (package): 68599350202
ndc11 (package): 68599350007
spl id: 5723cbb0-602e-0c21-e063-6394a90acfcd
spl set id: 33fa233c-b43c-42d8-af37-a58f098a0d51

Reported adverse events (FAERS/openFDA)#

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