SPL v5
SPL
SPL Set ID 33fa233c-b43c-42d8-af37-a58f098a0d51
Route
TOPICAL
Published
Effective Date 2017-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1 mg)
Inactive Ingredients
Citric Acid Monohydrate Sodium Phosphate, Dibasic, Anhydrous Glycerin Water Sodium Citrate Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-17
Description

Drug Facts

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses
  • Health-care antiseptic preparation of the skin prior to surgery.
  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
Do Not
  • 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
Section 42229-5

Drug Facts

Warnings

For external use only

Active Ingredient

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

Other 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

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

As A First Aid Antiseptic
  • 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
Stop Use and Ask A Doctor If
  • conditions persists or gets worse
  • irritation and redness develop and persists for more than 72 hours
Keep Out of the Reach of Children.

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

For Preparation of the Skin Prior to Surgery
  • Apply product to the operative site prior to surgery
Principal Display Panel Mckesson Pvp Prep Solution 1 Gal Label

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

Principal Display Panel Mckesson Pvp Prep Solution 4 Fl Oz Label

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

Principal Display Panel Mckesson Pvp Prep Solution 16 Fl Oz Label

NDC 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 8 Fl Oz. Label

NDC 68599-3502-5

McKESSON

PVP Prep Solution

USP 10%

POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

8 fl oz

(237 mL)

MFR # 034

Principal Display Panel Mckesson Pvp Prep Solution 1 Gal Carton Label

NDC 68599-3500-5

McKESSON

PVP Prep Solution USP

10% POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

1 gal

(3.8 L)

MFR# 036

Principal Display Panel Mckesson Pvp Prep Solution 4 Fl Oz Carton Label

NDC 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 16 Fl Oz Carton Label

NDC 68599-3500-1

McKESSON

PVP Prep Solution USP

10% POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

16 fl oz

(473 mL)

MFR# 035

Principal Display Panel Mckesson Pvp Prep Solution 8 Fl. Oz. Carton Label

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

Structured Label Content

Uses
  • Health-care antiseptic preparation of the skin prior to surgery.
  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
Do Not (Do not)
  • 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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Antiseptic

Warnings

For external use only

Active Ingredient

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

Other 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)

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

As A First Aid Antiseptic (As a first aid antiseptic)
  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions persists or gets worse
  • irritation and redness develop and persists for more than 72 hours
Keep Out of the Reach of Children. (Keep out of the reach of children.)

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

For Preparation of the Skin Prior to Surgery (For preparation of the skin prior to surgery)
  • Apply product to the operative site prior to surgery
Principal Display Panel Mckesson Pvp Prep Solution 1 Gal Label (Principal Display Panel - McKesson PVP Prep Solution 1 gal label)

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

Principal Display Panel Mckesson Pvp Prep Solution 4 Fl Oz Label (Principal Display Panel - McKesson PVP Prep Solution 4 fl oz label)

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

Principal Display Panel Mckesson Pvp Prep Solution 16 Fl Oz Label (Principal Display Panel - McKesson PVP Prep Solution 16 fl oz label)

NDC 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 8 Fl Oz. Label (Principal Display Panel - McKesson PVP Prep Solution 8 fl oz. label)

NDC 68599-3502-5

McKESSON

PVP Prep Solution

USP 10%

POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

8 fl oz

(237 mL)

MFR # 034

Principal Display Panel Mckesson Pvp Prep Solution 1 Gal Carton Label (Principal Display Panel - McKesson PVP Prep Solution 1 gal Carton label)

NDC 68599-3500-5

McKESSON

PVP Prep Solution USP

10% POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

1 gal

(3.8 L)

MFR# 036

Principal Display Panel Mckesson Pvp Prep Solution 4 Fl Oz Carton Label (Principal Display Panel - McKesson PVP Prep Solution 4 fl oz Carton label)

NDC 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 16 Fl Oz Carton Label (Principal Display Panel - McKesson PVP Prep Solution 16 fl oz Carton label)

NDC 68599-3500-1

McKESSON

PVP Prep Solution USP

10% POVIDONE IODINE

TOPICAL ANTISEPTIC MICROBICIDE

NET CONTENTS

16 fl oz

(473 mL)

MFR# 035

Principal Display Panel Mckesson Pvp Prep Solution 8 Fl. Oz. Carton Label (Principal Display Panel - McKesson PVP Prep Solution 8 fl. oz. Carton Label)

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

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Source: dailymed · Ingested: 2026-02-15T12:03:44.953172 · Updated: 2026-03-14T23:03:58.855522