Label: MCKESSON PVP PREP SOLUTION- povidone-iodine liquid

  • NDC Code(s): 68599-3500-1, 68599-3500-2, 68599-3500-5, 68599-3500-6, view more
    68599-3502-1, 68599-3502-2, 68599-3502-5, 68599-3502-6
  • Packager: McKesson Medical-Surgical
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

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

  • Purpose

    Antiseptic

  • Uses

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

    For external use only

    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

    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.

  • Directions

    For preparation of the skin prior to surgery

    • Apply product to the operative site prior to surgery

    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
  • 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

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

    039 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

    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 case

  • 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

    035 Each

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

    035 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

    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 each

  • 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

    036 case

  • 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

    034 each

  • 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

    034 case

  • INGREDIENTS AND APPEARANCE
    MCKESSON PVP PREP  SOLUTION
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-3502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-3502-236 in 1 CASE10/20/2016
    1NDC:68599-3502-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68599-3502-624 in 1 CASE03/13/2017
    2NDC:68599-3502-5237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00310/17/2016
    MCKESSON PVP PREP  SOLUTION
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-3500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-3500-212 in 1 CASE10/20/2016
    1NDC:68599-3500-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68599-3500-64 in 1 CASE10/20/2016
    2NDC:68599-3500-53800 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00310/17/2016
    Labeler - McKesson Medical-Surgical (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Degassa812771980manufacture(68599-3502, 68599-3500)
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